Efficacy of Fully Covered Self-Expanding Metal Stents Removal versus Stent- in-Stent Techniques in Recurrent Malignant Distal Biliary Obstruction

Efficacy of Fully Covered Self-Expanding Metal Stents Removal versus Stent- in-Stent Techniques in Recurrent Malignant Distal Biliary Obstruction | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Efficacy of Fully Covered Self-Expanding Metal Stents Removal versus Stent- in-Stent Techniques in Recurrent Malignant Distal Biliary Obstruction See Young Lee, Sung Ill Jang, Eui Joo Kim, Dong Ki Lee, Yeseul Seong, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5930361/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 24 Feb, 2026 Read the published version in Scientific Reports → Version 1 posted 10 You are reading this latest preprint version Abstract Fully covered self-expandable metal stents (FCSEMSs) are widely used in managing malignant distal biliary obstruction (MDBO). However, recurrent biliary obstruction (RBO) has become a significant challenge due to improved patient survival with advanced chemotherapy. This multicenter retrospective cohort study evaluated revision techniques for FCSEMS dysfunction in 159 patients with MDBO initially treated with FCSEMSs. Patients were categorized into four groups based on the revision method: stent exchange with self-expandable metal stents (SEMS, n=53) or plastic stents (n=23), and stent-in-stent placement with SEMS (n=51) or plastic stents (n=32). All procedures achieved 100% technical and clinical success. The primary time to recurrent biliary obstruction (TRBO) showed no significant difference among the groups (mean: 142 days, 95% confidence interval [CI]: 121–164 days). However, secondary TRBO differed significantly (p=0.014): 161 days (SEMS, stent exchange), 53 days (plastic stent, stent exchange), 104 days (SEMS, stent-in-stent), and 67 days (plastic stent, stent-in-stent). Multivariate analysis revealed that stent-in-stent placement with SEMS increased the risk of RBO compared to SEMS stent exchange (hazard ratio [HR]: 6.84, 95% CI: 1.89–22.55, p=0.003). Additionally, revision within 180 days was associated with a higher risk of RBO (HR: 1.77, 95% CI: 1.10–2.86, p=0.019). Overall survival was comparable across all groups. These findings suggest that SEMS stent exchange after FCSEMS removal is an effective revision method for RBO in MDBO, providing improved secondary stent patency without increasing adverse events or affecting overall survival. Biological sciences/Cancer/Gastrointestinal cancer Biological sciences/Cancer/Gastrointestinal cancer/Biliary tract cancer Biological sciences/Cancer/Gastrointestinal cancer/Pancreatic cancer Health sciences/Gastroenterology/Gastrointestinal diseases/Biliary tract disease/Bile duct disease Malignant distal biliary obstruction Recurrent biliary obstruction Revision method Stent patency Figures Figure 1 Figure 2 Figure 3 Introduction Endoscopic retrograde cholangiopancreatography (ERCP) guided biliary stenting is the primary therapeutic approach for biliary decompression in malignant distal biliary obstruction (MDBO) 1 , 2 . Advances in oncologic therapies have prolonged the survival of patients with pancreaticobiliary cancer, often surpassing the primary patency of the initial stent 3 , 4 . As a result, recurrent biliary obstruction (RBO) has become a significant clinical challenge. Fully covered self-expandable metal stents (FCSEMS) are increasingly preferred for initial intervention due to their removability and superior patency 5 , 6 . However, managing RBO after self-expandable metal stent (SEMS) occlusion often necessitates multiple interventions to restore biliary drainage. These interventions include mechanical cleaning, additional stent placement, or replacing the occluded stent with another SEMS or a plastic stent 7 . While SEMS are well established as the first-line treatment for MDBO, the optimal strategy for managing RBO remains unclear 7 – 9 . Current guidelines lack a standardized approach, although there is a general consensus that endoscopic reintervention is preferred over external drainage and that placing a new metal stent is the recommended strategy 10 . Some guidelines suggest that occluded FCSEMS should be removed and replaced with a new stent to maximize long-term patency 11 . However, recent studies indicate that the stent-in-stent technique may serve as an effective rescue therapy when an FCSEMS occludes in the setting of MDBO 12 . To date, no large-scale clinical trials have definitively demonstrated that stent removal is superior to leaving the stent in place. Given this uncertainty, this study aims to evaluate the effects of various modification strategies following primary FCSEMS dysfunction in MDBO. Key outcomes, including stent patency, overall survival, and adverse event rates, were analyzed, with a particular focus on comparing SEMS versus plastic stents, covered versus uncovered SEMS, and different stent replacement techniques. Results Patient characteristics This study included 159 patients with MDBO, with a mean age of 68.5 years (range: 36–89 years), and 54% were male. The most common cause of MDBO was pancreatic cancer (62%), followed by cholangiocarcinoma (21%) and ampullary cancer (17%). Baseline characteristics, including age, sex, cancer type, TNM stage, presence of duodenal strictures, and initial bilirubin levels, were comparable across all four groups (p > 0.05 for all comparisons) ( Table 1 ). The mean length of biliary strictures was also similar among the groups (range: 25.6–30.1 mm, p = 0.265). To assess potential differences between stent exchange and stent-in-stent placement, we conducted a subgroup analysis. No significant differences were found in baseline characteristics between these two groups ( Supplementary table 1 , p > 0.05). Additionally, considering the differences between covered and uncovered SEMS, we performed another subgroup analysis. No significant differences were observed in baseline characteristics between patients with covered SEMS and uncovered SEMS ( Supplementary table 2 , p > 0.05). Primary and secondary biliary stent patency and outcomes This study achieved 100% technical and clinical success rates across all intervention groups, demonstrating procedural efficacy (Table 2 ). Kaplan–Meier analysis showed no significant differences among the four groups in primary time to recurrent biliary obstruction (TRBO) (Fig. 1 A, log-rank test, p = 0.185). The mean primary TRBO across all patients was 142 days (95% CI: 121–164 days). Stent dysfunction patterns varied among groups. Ingrowth and overgrowth were more frequent in the stent-in-stent SEMS (58.9%) and stent-in-stent plastic stent (46.9%) groups (p = 0.007). Stone or sludge formation was most common in the stent exchange SEMS group (58.5%), although the difference among groups was not statistically significant (p = 0.068). Migration occurred exclusively in the stent exchange groups (22.6% in SEMS, 39.1% in plastic stents) and was absent in the stent-in-stent groups (p < 0.001). The mean secondary stent length was not significantly different across groups (range: 7.1–7.8 cm, p = 0.218). However, the secondary TRBO varied significantly among the groups (p = 0.014), with the longest duration in the stent exchange SEMS group (161 days), followed by stent-in-stent SEMS (104 days), stent-in-stent plastic stents (67 days), and stent exchange plastic stents (53 days). Further Kaplan–Meier analysis confirmed significant distinctions in secondary TRBO (Fig. 1 B, p < 0.001). Further, no significant differences in postprocedural complications or overall survival rates were observed among the groups. The early complication rate (< 1 month) was comparable across groups (p = 0.973), with acute cholangitis being the most common early complication (4.4–9.8%, p = 0.870). The late complication rate (≥ 1 month) also showed no significant differences (p = 0.606). The total complication rate ranged from 70.6–87.5% but did not significantly differ among groups (p = 0.111). The mean overall survival time was longest in the stent exchange SEMS group (478 days), followed by stent-in-stent plastic stents (434 days), stent exchange plastic stents (339 days), and stent-in-stent SEMS (337 days), though this difference was not statistically significant (p = 0.259). Kaplan–Meier curves for overall survival showed no significant differences (Fig. 2 , p = 0.172). The mean secondary TRBO was longer in the stent exchange group (128 days) compared to the stent-in-stent group (90 days), though this difference was not statistically significant (p = 0.135, Supplementary table 3 ). However, Kaplan–Meier analysis revealed a significant difference in secondary stent patency between the two groups (log-rank p = 0.035, Supplementary Fig. 1 ), indicating a potential advantage of stent exchange over stent-in-stent for prolonged secondary stent patency. The mean overall survival time was 439 days in the stent exchange group and 377 days in the stent-in-stent group, with no statistically significant difference between the two (p = 0.325). Kaplan–Meier survival analysis further confirmed that there was no significant difference in overall survival between the two groups (log-rank p = 0.294, Supplementary Fig. 2 ). Secondary stent outcomes, complication rates, and overall survival were comparable between covered and uncovered SEMS within each revision method ( Supplementary table 4 ). For the stent exchange group, the median secondary TRBO was 186 days for covered SEMS and 121 days for uncovered SEMS (p = 0.265), and 109 days and 102 days, respectively, for the stent-in-stent group (p = 0.812). The overall survival was also similar, with 550 days for covered SEMS and 406 days for uncovered SEMS in the stent exchange group (p = 0.270), and 314 days and 383 days, respectively, in the stent-in-stent group (p = 0.403). These findings indicate that secondary TRBO rates, complication rates, and survival outcomes do not significantly differ between covered and uncovered SEMS within each technique. Kaplan–Meier survival analysis also revealed no statistically significant differences in primary and secondary stent patency (p = 0.782, p = 0.498) or overall survival (p = 0.654, p = 0.276) based on the secondary stent insertion or stent exchange method in the stent-in-stent procedure using covered and uncovered SEMS ( Supplementary Figs. 3–6 ). Table 1. Baseline characteristics of patients and clinical outcomes according to the primary and secondary biliary stent type and method Stent exchange, SEMS (covered & uncovered) (n=53) Stent exchange, plastic stent (n=23) Stent-in-stent, SEMS (covered & uncovered) (n=51) Stent-in-stent, plastic stent (n=32) p-value Age (range) (years) 71.8 (48–89) 70.5 (40–86) 69.6 (47–89) 67.9 (36–88) 0.323 Sex Male/female (n) 26/27 11/12 29/22 15/17 0.781 Diagnosis Pancreatic cancer, n (%) 33 (62.3) 10 (43.5) 30 (58.8) 19 (59.4) 0.492 GB cancer, n (%) 2 (3.8) 3 (13.0) 4 (7.8) 1 (3.1) 0.379 CBD cancer, n (%) 13 (24.5) 7 (30.4) 12 (23.5) 9 (28.1) 0.913 AOV cancer, n (%) 4 (7.5) 1 (4.3) 3 (5.9) 2 (6.3) 0.960 Metastatic disease, n (%) 1 (1.9) 2 (8.7) 2 (3.9) 1 (3.1) 0.556 TNM stage III, n (%) 23 (43.4) 10 (43.5) 23 (45.1) 17 (53.1) 0.387 IV, n (%) 30 (56.6) 13 (56.5) 28 (54.9) 15 (46.9) 0.387 Duodenal stricture, n (%) 4 (7.5) 0 (0.0) 0 (0.0) 2 (6.3) 0.139 Length of biliary stricture (mm) 26.7 29.6 25.6 30.1 0.265 CTx. ± CCRTx., n (%) 43 (81.1) 16 (69.6) 29 (56.9) 27 (84.4) 0.149 Total bilirubin (mg/dL) Baseline 7.0 6.7 7.6 6.8 0.886 Day 1 5.8 5.7 5.8 5.2 0.873 Day 28 1.4 2.1 1.4 2.1 0.282 Previous procedure, n (%) 17 (32.1) 8 (34.8) 12 (23.5) 8 (25.0) 0.663 AOV, ampulla of vater; CBD, common bile duct; CCRTx., concurrent chemoradiotherapy; CTx., chemotherapy; GB, gallbladder; SEMS, self-expandable metallic stent; TNM, classification of malignant tumors Table 2 Primary and secondary biliary stent patency and outcomes according to stent type and method Stent exchange, SEMS (covered & uncovered) (n = 53) Stent exchange, plastic stent (n = 23) Stent-in-stent, SEMS (covered & uncovered) (n = 51) Stent-in-stent, plastic stent (n = 32) p-value Primary stent outcome Primary stent length (cm) 6.4 6.2 6.1 6.5 0.605 Primary TRBO (day, mean) 161 106 154 128 0.108 Cause of stent dysfunction Ingrowth & overgrowth, n (%) 10 (18.8) 5 (21.7) 30 (58.9) 15 (46.9) 0.007 Stone & sludge, n (%) 34 (58.5) 9 (39.1) 21 (41.2) 17 (36.3) 0.068 Migration, n (%) 12 (22.6) 9 (39.1) 0 (0.0) 0 (0.0) < 0.001 Secondary stent outcome Secondary stent length (cm) 7.1 7.8 7.5 7.7 0.218 Secondary TRBO (day, mean) 161 53 104 67 0.014 Early complication (< 1m) Acute pancreatitis, n (%) 0 (0.0) 1 (4.4) 0 (0.0) 1 (3.1) 0.265 Acute cholangitis, n (%) 4 (7.6) 1 (4.4) 5 (9.8) 3 (9.4) 0.870 Migration, n (%) 2 (3.8) 1 (4.4) 0 (0.0) 0 (0.0) 0.599 Total, n (%) 6 (11.3) 3 (13.0) 5 (9.8) 4 (12.5) 0.973 Late complication (≥ 1m) Acute pancreatitis, n (%) 1 (1.9) 0 (0.0) 3 (5.9) 1 (3.1) 0.520 Acute cholangitis, n (%) 29 (54.7) 10 (43.5) 27 (52.9) 19 (59.4) 0.705 Migration, n (%) 6 (11.3) 5 (21.7) 1 (2.0) 4 (12.5) 0.060 Total, n (%) 36 (67.9) 15 (65.2) 31 (60.8) 24 (75.0) 0.606 Total complication, n (%) 42 (79.3) 18 (78.3) 36 (70.6) 28 (87.5) 0.111 Overall survival time (day, mean) 478 339 337 434 0.259 SEMS, self-expandable metallic stent; TRBO, time to recurrent biliary obstruction Univariate and multivariate cox regression analysis Univariate and multivariate Cox regression analyses were performed to assess factors influencing secondary TRBO (Table 3 ). Univariate analysis indicated that revisions performed within 180 days significantly increased the risk of secondary TRBO (HR: 1.79, 95% CI: 1.13–2.84, p = 0.013). Primary stent malfunction owing to metastasis, rather than tumor growth, was associated with a reduced risk of secondary TRBO (HR: 0.31, 95% CI: 0.13–0.75, p = 0.009). According to the revision method, stent exchange with plastic stents (median TRBO: 53 days) and stent-in-stent with plastic stents (median TRBO: 67 days) were associated with significantly higher risks of secondary TRBO compared to stent exchange with SEMS (HR: 3.62, 95% CI: 1.63–8.03; HR: 3.58, 95% CI: 1.84–6.99). Multivariate analysis, accounting for primary TRBO duration, cause of primary stent dysfunction, and cancer type, revealed that shorter primary TRBO (HR: 1.77, 95% CI: 1.10–2.86), stent migration (HR: 0.30, 95% CI: 0.13–0.68), and revision method significantly influenced secondary TRBO. Stent exchange with plastic stents had the highest HR for secondary TRBO (HR: 6.84, 95% CI: 2.63–17.80), followed by stent-in-stent with SEMS (HR: 6.53, 95% CI: 1.89–22.55) and plastic stents (HR: 2.69, 95% CI: 1.21–5.97). Cox regression models for overall survival showed no significant differences between revision methods, indicating that the choice of strategy does not directly affect long-term survival outcomes (Table 4 ). Table 3 Univariate and multivariate analysis of variables associated with secondary biliary stent patency n Median (day) Univariate analysis Multivariate analysis HR 95% CI p-value HR 95% CI p-value Diagnosis Pancreatic cancer 92 69 1.00 Ref. 1.00 Ref. GB cancer 10 72 1.02 0.37–2.81 0.976 0.72 0.25–2.08 0.543 CBD cancer 41 61 1.11 0.70–1.76 0.657 0.91 0.52–1.59 0.728 AoV cancer 10 91 1.09 0.50–2.40 0.828 1.63 0.69–3.86 0.264 Metastasis 6 50 2.90 1.04–8.13 0.043 1.61 0.50–5.20 0.424 TNM stage III 73 65 1.00 0.605 IV 86 72 1.13 0.71–1.79 Length of biliary stricture ≥ 25mm 74 69.5 1.00 0.919 3mg/dL 93 356 1.30 0.79–2.15 Primary TRBO ≥ 180days 47 93 1.00 0.013 1.00 0.019 < 180days 112 67 1.79 1.13–2.84 1.77 1.10–2.86 Cause of primary stent dysfunction Ingrowth & overgrowth 55 60 1.00 Ref. 1.00 Ref. Stone, sludge 83 72 1.69 0.96–2.99 0.069 1.50 0.90–2.51 0.123 Migration 21 77 0.31 0.13–0.75 0.009 0.30 0.13–0.68 0.004 Method Stent exchange, SEMS 53 94 1.00 Ref. 1.00 Ref. Stent exchange, Plastic stent 23 53 3.62 1.63–8.03 0.002 6.84 2.63–17.8 < 0.001 Stent-in-Stent, SEMS 51 75 1.72 0.98–3.02 0.059 6.53 1.89–22.55 0.003 Stent-in-Stent, Plastic stent 32 67 3.58 1.84–6.99 < 0.001 2.69 1.21–5.97 0.015 AOV, ampulla of vater; CBD, common bile duct; CCRTx., concurrent chemoradiotherapy; CTx., chemotherapy; GB, gallbladder; SEMS, self-expandable metallic stent; TNM, classification of malignant tumors; TRBO, time to recurrent biliary obstruction Table 4 Univariate and multivariate analysis of variables associated with overall survival time n Median (day) Univariate analysis Multivariate analysis HR 95% CI p-value HR 95% CI p-value Diagnosis Pancreatic cancer 92 348 1.00 Ref. GB cancer 10 173 1.51 0.36–6.35 0.573 CBD cancer 41 334 1.33 0.75–2.38 0.333 AoV cancer 10 546 0.71 0.12–4.17 0.705 Metastasis 6 158 1.64 0.87–3.10 0.129 TNM stage III 73 385 1.00 0.079 1.00 0.009 IV 86 333 1.61 0.95–2.75 2.26 1.23–4.16 Length of biliary stricture ≥ 25mm 74 342 1.00 0.853 3mg/dL 93 324 1.75 1.00–3.05 1.755 1.00–3.07 Primary TRBO ≥ 180days 47 474 1.00 0.005 1.00 0.019 < 180days 112 280 2.46 1.32–4.60 1.77 1.10–2.86 Cause of primary stent dysfunction Ingrowth & overgrowth 55 294 1.00 Ref. Stone, sludge 83 338 0.88 0.48–1.58 0.659 Migration 21 385 0.76 0.30–1.93 0.557 Method Stent exchange, SEMS 53 396 1.00 Ref. 1.00 Ref. Stent exchange, Plastic stent 23 348 0.80 0.35–1.83 0.591 0.83 0.31–2.22 0.704 Stent-in-Stent, SEMS 51 285 1.30 0.45–3.77 0.630 1.35 0.41–4.43 0.625 Stent-in-Stent, Plastic stent 32 334 1.59 0.89–2.86 0.120 1.17 0.58–2.36 0.658 AOV, ampulla of vater; CBD, common bile duct; CCRTx., concurrent chemoradiotherapy; CTx., chemotherapy; GB, gallbladder; SEMS, self-expandable metallic stent; TNM, classification of malignant tumors; TRBO, time to recurrent biliary obstruction Discussion Overall the present study demonstrated that, stent replacement with SEMS was more effective in prolonging secondary stent patency compared to stent-in-stent or plastic stents in patients who developed RBO after using FCSEMS as a primary stent for MDBO. Unlike uncovered SEMS, covered SEMS provide greater versatility, including options such as stent removal and reinsertion. This study aimed to compare and analyze differences in secondary TRBO and overall survival across various revision methods among patients with FCSEMS. Overall, we found a significant difference in secondary TRBO among the four groups: stent exchange with SEMS, stent-in-stent with SEMS, stent exchange with plastic stents, and stent-in-stent with plastic stents. Kaplan–Meier and univariate analyses confirmed the superiority of SEMS over plastic stents, consistent with previous studies 13 , 14 . However, multivariate analysis, incorporating variables from univariate analysis and key clinical factors, demonstrated the superiority of stent exchange with SEMS over stent-in-stent with SEMS in secondary stent patency. While previous studies have reported on the effectiveness of stent-in-stent when metallic primary stents are occluded 7 , this analysis identified that stent exchange is more effective when the primary stent is limited to FCSEMS. Overall survival analysis revealed that the revision methodology did not significantly influence survival duration. Multivariate analysis identified TNM stage, chemotherapy status, and jaundice as critical factors associated with cancer prognosis, thereby highlighting the need to prioritize these factors in cancer management 15 , 16 . Additionally, a significant correlation was found between shorter primary TRBO and decreased survival. Early SEMS occlusion may increase the risk of subsequent occlusion, likely influenced by tumor size, stenosis degree, or location 17 , 18 . Frequent drainage owing to shorter TRBOs can increase risks of further obstruction and cholangitis, ultimately reducing survival 19 – 21 . Although prior studies have reported more frequent cholecystitis and stent migration with covered SEMS 22 , no significant differences in complication rates were observed in this study across procedure methods or SEMS types. These findings indicate that patient clinical characteristics, procedural experience, or recent advances in stent design may have contributed to these results. Further research is thus required to identify risk factors for complications associated with covered SEMS. The results of this study emphasize the efficacy of using FCSEMS as the primary stent for MDBO, followed by stent exchange with SEMS as a revision strategy. A key question raised is the optimal timing for stent exchange. While exchange is clearly indicated when RBO criteria are met or stent dysfunction occurs, the average duration of stent exchange in this study was 4–5 months, with a range of 18 to 420 days. A thorough assessment of stent function around 4–5 months may facilitate the early detection of RBO or dysfunction, potentially improving patient outcomes by enabling timely intervention. Additionally, as FCSEMS has demonstrated stent patency for up to 14 months, assessing stent function at 1 year appears to be clinically important. This study faced limitations owing to an imbalance in patient numbers among the groups, with the small sample sizes precluding equalization through propensity score matching. To strengthen these findings, future studies should aim to enroll a larger, more balanced cohort, ideally in a multicenter setting, to enable more robust comparisons. Furthermore, growing interest in partially covered SEMS, which combine features of covered and uncovered stents, warrants investigation 23 , 24 . These stents may offer unique advantages and challenges in managing biliary strictures. Follow-up studies should explore the efficacy, safety, and specific indications of various covered SEMS types in clinical practice. In conclusion, the present study showed when RBO occurs after initial placement of an FCSEMS for MDBO, stent exchange with SEMS offers an effective alternative, providing superior secondary stent patency without increasing adverse events or negatively impacting overall survival. Methods Study design and patients This multicenter, retrospective study compared the efficacy and safety of various revision methods for RBO following FCSEMS insertion. Patients who underwent ERCP for MBO at one of the three university hospitals between March 2013 and March 2023 were considered eligible. The inclusion criteria included: (1) adults aged ≥ 20 years, (2) unresectable MDBO, (3) initial stenting with FCSEMS, and (4) available for follow-up until secondary stent dysfunction. Exclusion criteria included: (1) malignant hilar or intrahepatic duct stricture, (2) initial stent insertion with an uncovered SEMS, (3) loss to follow-up after secondary stenting, (4) percutaneous procedures, (5) endoscopic ultrasound-guided procedures, and (6) contraindications to ERCP, pregnancy, or breastfeeding. The study endpoints were clinical outcomes, complications, and prognoses. A total of 159 patients with MDBO were included, including 76 patients treated with the stent exchange method and 83 with the stent-in-stent method. In the stent exchange group, 53 patients received SEMS and 23 plastic stents, whereas in the stent-in-stent group, 51 patients received SEMS and 32 plastic stents (Fig. 3 ). Ethics Approval This study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board (IRB) of Gangnam Severance Hospital (approval number: 3-2022-0248). The requirement for informed consent was waived owing to the retrospective nature of the study. All patient data were anonymized before analysis. Procedure details and revision techniques RBO was managed using two revision techniques: (1) stent replacement, involving removal of the existing FCSEMS followed by re-stenting, or (2) stent-in-stent, in which an additional stent was placed without removing the existing FCSEMS. Stents used during reintervention included SEMS (covered or uncovered) and plastic stents. The choice of stent type, length, and diameter was determined by an expert endoscopist, based on the patient’s MBO characteristics. ERCP was performed under sedation using diazepam, midazolam, pethidine, and/or propofol, following written informed consent. Duodenoscopes (JF260V or JF290V, Olympus, Tokyo, Japan) were used. The decision to perform balloon sweeping was made by the endoscopist, considering the presence of bile duct sludge or cholangitis. Plastic stents included Advanix (Boston Scientific, USA) and Zimmon (Cook Medical, USA), with a diameter of 7 Fr and lengths of 5–8 cm. Commonly used uncovered SEMS included BONASTENT (SEWOON Medical, Korea) and Niti-S D-type (TaeWoong Medical, Korea), while covered SEMS included Hilzo (BCM Co., Korea) and HANAROSTENT (M.I.Tech, Korea). SEMS dimensions ranged from 8 to 10 mm in diameter and 5–8 cm in length, selected based on stricture length. Outcome and definition The primary outcome was secondary stent patency, defined as the TRBO according to the Tokyo criteria: the interval from stent deployment to dysfunction owing to migration, occlusion, or other causes requiring reintervention 25 , 26 . Overall survival was defined as the interval from first stent deployment to death. Technical success was defined as successful stent deployment confirmed by imaging. Clinical success was characterized by a ≥ 50% reduction in total bilirubin and symptom improvement (e.g., jaundice, abdominal pain, fever) within 1 month 7 . Stent migration was assessed using abdominal radiography or CT, with confirmation performed during follow-up. Stent occlusion was diagnosed radiologically (cholangiography, CT, or MRI) in patients with recurrent cholangitis or jaundice, with causes identified via cholangiography or duodenoscopy. MDBO diagnosis and type were determined using established criteria 27 , 28 . The study endpoint was secondary stent occlusion or death. Adverse events were evaluated based on the ESGE guidelines 29 . Statistical analysis Continuous variables were presented as medians and ranges, and categorical variables as percentages. The Mann–Whitney U test was used for continuous variables, whereas chi-square or Fisher’s exact tests were applied for categorical variables. Kaplan–Meier analysis and log-rank tests were applied to estimate and compare stent patency and overall survival. Univariate and multivariate Cox proportional hazards regression models were employed to identify factors associated with secondary TRBO and overall survival. Variables with p-values < 0.05 in univariate analysis and clinically significant variables were included in multivariate analysis. Statistical significance was set at p < 0.05, and all analyses were performed using SPSS version 25.0 and R version 4.2.1. Declarations Acknowledgements The authors have no acknowledgements to declare. Author Contributions Conceptualization: S. H. Lee, J. H. Cho; Data curation: S. Y. Lee, S. I. Jang, E. J. Kim, D. K. Lee, H. S. Lee, I. R. Cho, W. H. Paik, J. K. Ryu, S. H. Lee, J. H. Cho; Formal analysis: S. Y. Lee; Funding acquisition: S. H. Lee, J. H. Cho; Investigation: S. H. Lee, J. H. Cho; Methodology: S. Y. Lee, S. H. Lee, J. H. Cho; Software: S. Y. Lee, Y. Seong; Validation: S. H. Lee, J. H. Cho; Visualization: S. Y. Lee, S. H. Lee, J. H. Cho; Writing—original draft: S. Y. Lee, S. H. Lee, J. H. Cho; Writing—review & editing: S. Y. Lee, S. I. Jang, E. J. Kim, D. K. Lee, H. S. Lee, I. R. Cho, W. H. Paik, J. K. Ryu, S. H. Lee, J. H. Cho. Funding This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Ministry of Science and ICT (MSIT), Korea government (No. NRF-2022R1A2C1009842), and a new faculty research initiation grant from Yonsei University College of Medicine for 2024 (2024-32-0044). Competing Interests Authors declare no conflict of interests for this article. Data availability The datasets used and/or analyzed in this study are available from the corresponding author upon reasonable request. References Dumonceau, J. M. et al. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017. 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Endoscopy 50 , 910-930 (2018). Ito, K., Ogawa, T., Horaguchi, J., Koshita, S. & Fujita, N. Reintervention for occluded biliary metal stent for patients with malignant distal biliary stricture. Dig Endosc 25 Suppl 2 , 126-131 (2013). Tejedor-Tejada, J. et al. Secondary uncovered versus fully-covered metal stents for the management of occluded stent in unresectable distal malignant biliary obstruction. Gastroenterol Hepatol 47 , 502218 (2024). Almadi, M. A., Barkun, A. & Martel, M. Plastic vs. Self-Expandable Metal Stents for Palliation in Malignant Biliary Obstruction: A Series of Meta-Analyses. Am J Gastroenterol 112 , 260-273 (2017). Gomez, C. A. M. et al. Covered vs. Uncovered Self-Expandable Metallic Stents (SEMS) for Malignant Distal Biliary Obstruction (MDBO). Gastrointestinal Endoscopy 69 (2009). Mizrahi, J. D., Surana, R., Valle, J. W. & Shroff, R. T. Pancreatic cancer. Lancet 395 , 2008-2020 (2020). Valle, J. W., Kelley, R. K., Nervi, B., Oh, D. Y. & Zhu, A. X. Biliary tract cancer. Lancet 397 , 428-444 (2021). Nennstiel, S. et al. Management of occluded self-expanding biliary metal stents in malignant biliary disease. Hepatobiliary Pancreat Dis Int 17 , 49-54 (2018). Isayama, H. et al. Endoscopic retrograde cholangiopancreatography for distal malignant biliary stricture. Gastrointest Endosc Clin N Am 22 , 479-490 (2012). Ridtitid, W. et al. Outcome of second interventions for occluded metallic stents in patients with malignant biliary obstruction. Surg Endosc 24 , 2216-2220 (2010). Bueno, J. T., Gerdes, H. & Kurtz, R. C. Endoscopic management of occluded biliary Wallstents: a cancer center experience. Gastrointest Endosc 58 , 879-884 (2003). Zhou, H., Khizar, H., Ali, A. & Yang, J. Safety and efficacy of side-by-side versus stent-in-stent stenting for malignant hilar biliary obstruction: a systematic review and meta-analysis. Therap Adv Gastroenterol 17 , 17562848241271962 (2024). Tringali, A. et al. Covered vs. uncovered self-expandable metal stents for malignant distal biliary strictures: a systematic review and meta-analysis. Endoscopy 50 , 631-641 (2018). Yamada, M. et al. Outcomes of Intraductal Placement of Covered Metal Stents for Unresectable Distal Malignant Biliary Obstruction. J Clin Med 12 (2023). Miyazawa, M. et al. Efficacy of a novel self-expandable metal stent with dumbbell-shaped flare ends for distal biliary obstruction due to unresectable pancreatic cancer. Sci Rep 12 , 21100 (2022). Paik, W. H. et al. Efficacy of an internal anchoring plastic stent to prevent migration of a fully covered metal stent in malignant distal biliary strictures: a randomized controlled study. Endoscopy 53 , 578-585 (2021). Isayama, H. et al. TOKYO criteria 2014 for transpapillary biliary stenting. Dig Endosc 27 , 259-264 (2015). Nakai, Y., Hamada, T., Isayama, H., Itoi, T. & Koike, K. Endoscopic management of combined malignant biliary and gastric outlet obstruction. Dig Endosc 29 , 16-25 (2017). Mutignani, M. et al. Combined endoscopic stent insertion in malignant biliary and duodenal obstruction. Endoscopy 39 , 440-447 (2007). Dumonceau, J. M. et al. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy 52 , 127-149 (2020). Additional Declarations No competing interests reported. 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Medicine","correspondingAuthor":false,"prefix":"","firstName":"Sung","middleName":"Ill","lastName":"Jang","suffix":""},{"id":415412506,"identity":"34b2f7d0-d1f1-476c-91da-66de70f54acc","order_by":2,"name":"Eui Joo Kim","email":"","orcid":"","institution":"Gachon University College of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Eui","middleName":"Joo","lastName":"Kim","suffix":""},{"id":415412507,"identity":"caae5317-b2f9-48df-9754-0fef50ee1eab","order_by":3,"name":"Dong Ki Lee","email":"","orcid":"","institution":"Yonsei University College of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Dong","middleName":"Ki","lastName":"Lee","suffix":""},{"id":415412508,"identity":"b0cef3b1-e793-42c1-9b50-0b39addbd387","order_by":4,"name":"Yeseul Seong","email":"","orcid":"","institution":"Yonsei University College of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Yeseul","middleName":"","lastName":"Seong","suffix":""},{"id":415412509,"identity":"6f8cbeb6-a277-4646-abc5-0067db26813c","order_by":5,"name":"Jung Hyun Jo","email":"","orcid":"","institution":"Yonsei University College of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Jung","middleName":"Hyun","lastName":"Jo","suffix":""},{"id":415412510,"identity":"bd963b54-3ee6-447b-9641-d4893720fe52","order_by":6,"name":"Chan Min Jung","email":"","orcid":"","institution":"Yonsei University College of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Chan","middleName":"Min","lastName":"Jung","suffix":""},{"id":415412511,"identity":"e6c89bca-f0f5-4164-9571-9c340093d85a","order_by":7,"name":"Hyun Seok Lee","email":"","orcid":"","institution":"Chungnam National University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Hyun","middleName":"Seok","lastName":"Lee","suffix":""},{"id":415412512,"identity":"3b4a6cf0-3e74-42c1-93a0-e08a16ad778f","order_by":8,"name":"In Rae Cho","email":"","orcid":"","institution":"Seoul National University College of Medicine","correspondingAuthor":false,"prefix":"","firstName":"In","middleName":"Rae","lastName":"Cho","suffix":""},{"id":415412513,"identity":"05073d29-30c9-4239-ba48-a03d08e2f19f","order_by":9,"name":"Woo Hyun Paik","email":"","orcid":"","institution":"Seoul National University College of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Woo","middleName":"Hyun","lastName":"Paik","suffix":""},{"id":415412514,"identity":"216df82c-d107-4e02-81d3-18476dcf5378","order_by":10,"name":"Ji Kon Ryu","email":"","orcid":"","institution":"Seoul National University College of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Ji","middleName":"Kon","lastName":"Ryu","suffix":""},{"id":415412515,"identity":"7227b4e0-dfef-4c74-a606-df50ffb75e5b","order_by":11,"name":"Sang Hyub Lee","email":"","orcid":"","institution":"Seoul National University College of Medicine","correspondingAuthor":false,"prefix":"","firstName":"Sang","middleName":"Hyub","lastName":"Lee","suffix":""},{"id":415412516,"identity":"26f79add-9e0d-4adf-a5bc-a31e2eea0692","order_by":12,"name":"Jae Hee Cho","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA2UlEQVRIiWNgGAWjYBACxhkMbAwMFTVy/OwNDMwkaDlzzFiy5wCRWhgkgFoY25gTN9xIIFIL8+zmZw8+trExzpz5xky64A+DPH8DIYfNOWZuOOOcDDO/dI6Z9Mw2BsMZBwhpmZHDJs1TxsYmORuohbeBgXEDIYdBtLAx8xjcPGMmzfOHwZ5ILW3MEgY3eIBa2BgSidCSZiY548wxA8metGJr3jaJZIJ+MZyR/EziQ0VNfT/74Y23ef7Y2PY3ENKCUMBhwACKJoJAHsFkf0BY+SgYBaNgFIxIAACqijrKkA76pQAAAABJRU5ErkJggg==","orcid":"","institution":"Yonsei University College of Medicine","correspondingAuthor":true,"prefix":"","firstName":"Jae","middleName":"Hee","lastName":"Cho","suffix":""}],"badges":[],"createdAt":"2025-01-30 12:53:06","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5930361/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5930361/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41598-026-40409-6","type":"published","date":"2026-02-24T15:58:41+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":76568831,"identity":"b599a7b1-7330-4539-a0db-5552137676b6","added_by":"auto","created_at":"2025-02-18 13:22:46","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":1135019,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eKaplan–Meier survival curves of primary and secondary stent patency according to the revision method.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(A) Kaplan–Meier survival curves of primary stent patency according to the revision method. The survival curves, as per the primary stent patency obtained by log-rank analysis, did not show any statistically significant differences (p = 0.185). \u003cstrong\u003e(B)\u003c/strong\u003e Kaplan–Meier survival curves for secondary stent patency following revision method. Survival curves were significantly different as per the secondary stent patency (log-rank analysis, p \u0026lt; 0.001). The stent exchange (SEMS) group demonstrated more favorable secondary stent patency compared to the plastic stent groups (hazard ratio [HR] 3.62; 95% class interval [CI] 1.63–8.03, and HR 3.58; 95% CI 1.84–6.99, respectively, p = 0.002 and p \u0026lt; 0.001). No statistical significance was observed between the SEMS group and the stent-in-stent [SEMS] group (HR 1.72; 95% CI 0.98–3.02, p = 0.059). SEMS, self-expandable metallic stent\u003c/p\u003e","description":"","filename":"Figure1scirep.png","url":"https://assets-eu.researchsquare.com/files/rs-5930361/v1/c7c859781e5535afb7add074.png"},{"id":76571123,"identity":"dd8de07f-7fd9-4aba-8057-a3530cfc2948","added_by":"auto","created_at":"2025-02-18 13:38:46","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":758310,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eKaplan–Meier survival curves of overall survival time\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(A) Kaplan–Meier survival curves of the overall survival time according to the primary and secondary biliary stent type and method. The survival curves, as per the overall survival time obtained by log-rank analysis, did not indicate any statistically significant differences (p = 0.172). (B) Kaplan–Meier survival curves of the overall survival time according to the secondary stenting method. The survival curves according to the overall survival time obtained by log-rank analysis did not suggest any statistically significant differences (p = 0.294). SEMS, self-expandable metallic stent\u003c/p\u003e","description":"","filename":"Figure2scirep.png","url":"https://assets-eu.researchsquare.com/files/rs-5930361/v1/94b3885e98b4f1efbcee1d15.png"},{"id":76571127,"identity":"296e62c4-56dd-406e-90e2-d7317cf56205","added_by":"auto","created_at":"2025-02-18 13:38:46","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":1145968,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlow diagram showing patient selection and categorization according to the primary stent and revision method.\u003c/strong\u003e SEMS, self-expandable metal stents; FCSEMS, fully covered SEMS\u003c/p\u003e","description":"","filename":"Figure3scirep.png","url":"https://assets-eu.researchsquare.com/files/rs-5930361/v1/d0ab13112b5b6e537414848c.png"},{"id":103766141,"identity":"4fd05d6f-adf7-492d-9667-92ba1f52c56b","added_by":"auto","created_at":"2026-03-02 16:12:28","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":5031459,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5930361/v1/00852f27-84b4-4a09-9ded-6ad6537adda7.pdf"},{"id":76570092,"identity":"533ce958-21c1-4e58-8067-684ef8a5a206","added_by":"auto","created_at":"2025-02-18 13:30:46","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":256084,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementaryfigurescirep20250212.docx","url":"https://assets-eu.researchsquare.com/files/rs-5930361/v1/f3a007f571afe0423992bc59.docx"},{"id":76568833,"identity":"1a12b6e1-304d-4240-8d1d-f6cec1a64c60","added_by":"auto","created_at":"2025-02-18 13:22:46","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":33175,"visible":true,"origin":"","legend":"","description":"","filename":"Supplementarytablescirep20250212.docx","url":"https://assets-eu.researchsquare.com/files/rs-5930361/v1/a7654d651f236794341c97f8.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Efficacy of Fully Covered Self-Expanding Metal Stents Removal versus Stent- in-Stent Techniques in Recurrent Malignant Distal Biliary Obstruction","fulltext":[{"header":"Introduction","content":"\u003cp\u003eEndoscopic retrograde cholangiopancreatography (ERCP) guided biliary stenting is the primary therapeutic approach for biliary decompression in malignant distal biliary obstruction (MDBO)\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e,\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e. Advances in oncologic therapies have prolonged the survival of patients with pancreaticobiliary cancer, often surpassing the primary patency of the initial stent\u003csup\u003e\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e,\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e. As a result, recurrent biliary obstruction (RBO) has become a significant clinical challenge. Fully covered self-expandable metal stents (FCSEMS) are increasingly preferred for initial intervention due to their removability and superior patency\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e,\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e. However, managing RBO after self-expandable metal stent (SEMS) occlusion often necessitates multiple interventions to restore biliary drainage. These interventions include mechanical cleaning, additional stent placement, or replacing the occluded stent with another SEMS or a plastic stent\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. While SEMS are well established as the first-line treatment for MDBO, the optimal strategy for managing RBO remains unclear\u003csup\u003e\u003cspan additionalcitationids=\"CR8\" citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e. Current guidelines lack a standardized approach, although there is a general consensus that endoscopic reintervention is preferred over external drainage and that placing a new metal stent is the recommended strategy\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u003c/sup\u003e. Some guidelines suggest that occluded FCSEMS should be removed and replaced with a new stent to maximize long-term patency\u003csup\u003e\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e. However, recent studies indicate that the stent-in-stent technique may serve as an effective rescue therapy when an FCSEMS occludes in the setting of MDBO\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e. To date, no large-scale clinical trials have definitively demonstrated that stent removal is superior to leaving the stent in place. Given this uncertainty, this study aims to evaluate the effects of various modification strategies following primary FCSEMS dysfunction in MDBO. Key outcomes, including stent patency, overall survival, and adverse event rates, were analyzed, with a particular focus on comparing SEMS versus plastic stents, covered versus uncovered SEMS, and different stent replacement techniques.\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec3\"\u003e\n \u003ch2\u003ePatient characteristics\u003c/h2\u003e\n \u003cp\u003eThis study included 159 patients with MDBO, with a mean age of 68.5 years (range: 36\u0026ndash;89 years), and 54% were male. The most common cause of MDBO was pancreatic cancer (62%), followed by cholangiocarcinoma (21%) and ampullary cancer (17%). Baseline characteristics, including age, sex, cancer type, TNM stage, presence of duodenal strictures, and initial bilirubin levels, were comparable across all four groups (p\u0026thinsp;\u0026gt;\u0026thinsp;0.05 for all comparisons) (\u003cstrong\u003eTable\u0026nbsp;1\u003c/strong\u003e). The mean length of biliary strictures was also similar among the groups (range: 25.6\u0026ndash;30.1 mm, p\u0026thinsp;=\u0026thinsp;0.265). To assess potential differences between stent exchange and stent-in-stent placement, we conducted a subgroup analysis. No significant differences were found in baseline characteristics between these two groups (\u003cstrong\u003eSupplementary table \u003cspan\u003e1\u003c/span\u003e\u003c/strong\u003e, p\u0026thinsp;\u0026gt;\u0026thinsp;0.05). Additionally, considering the differences between covered and uncovered SEMS, we performed another subgroup analysis. No significant differences were observed in baseline characteristics between patients with covered SEMS and uncovered SEMS (\u003cstrong\u003eSupplementary table \u003cspan\u003e2\u003c/span\u003e, p\u003c/strong\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e\n\u003c/div\u003e\n\u003ch3\u003ePrimary and secondary biliary stent patency and outcomes\u003c/h3\u003e\n\u003cp\u003eThis study achieved 100% technical and clinical success rates across all intervention groups, demonstrating procedural efficacy (Table\u0026nbsp;\u003cspan\u003e2\u003c/span\u003e). Kaplan\u0026ndash;Meier analysis showed no significant differences among the four groups in primary time to recurrent biliary obstruction (TRBO) (Fig.\u0026nbsp;\u003cspan\u003e1\u003c/span\u003eA, log-rank test, p\u0026thinsp;=\u0026thinsp;0.185). The mean primary TRBO across all patients was 142 days (95% CI: 121\u0026ndash;164 days). Stent dysfunction patterns varied among groups. Ingrowth and overgrowth were more frequent in the stent-in-stent SEMS (58.9%) and stent-in-stent plastic stent (46.9%) groups (p\u0026thinsp;=\u0026thinsp;0.007). Stone or sludge formation was most common in the stent exchange SEMS group (58.5%), although the difference among groups was not statistically significant (p\u0026thinsp;=\u0026thinsp;0.068). Migration occurred exclusively in the stent exchange groups (22.6% in SEMS, 39.1% in plastic stents) and was absent in the stent-in-stent groups (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The mean secondary stent length was not significantly different across groups (range: 7.1\u0026ndash;7.8 cm, p\u0026thinsp;=\u0026thinsp;0.218). However, the secondary TRBO varied significantly among the groups (p\u0026thinsp;=\u0026thinsp;0.014), with the longest duration in the stent exchange SEMS group (161 days), followed by stent-in-stent SEMS (104 days), stent-in-stent plastic stents (67 days), and stent exchange plastic stents (53 days). Further Kaplan\u0026ndash;Meier analysis confirmed significant distinctions in secondary TRBO (Fig.\u0026nbsp;\u003cspan\u003e1\u003c/span\u003eB, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Further, no significant differences in postprocedural complications or overall survival rates were observed among the groups. The early complication rate (\u0026lt;\u0026thinsp;1 month) was comparable across groups (p\u0026thinsp;=\u0026thinsp;0.973), with acute cholangitis being the most common early complication (4.4\u0026ndash;9.8%, p\u0026thinsp;=\u0026thinsp;0.870). The late complication rate (\u0026ge;\u0026thinsp;1 month) also showed no significant differences (p\u0026thinsp;=\u0026thinsp;0.606). The total complication rate ranged from 70.6\u0026ndash;87.5% but did not significantly differ among groups (p\u0026thinsp;=\u0026thinsp;0.111). The mean overall survival time was longest in the stent exchange SEMS group (478 days), followed by stent-in-stent plastic stents (434 days), stent exchange plastic stents (339 days), and stent-in-stent SEMS (337 days), though this difference was not statistically significant (p\u0026thinsp;=\u0026thinsp;0.259). Kaplan\u0026ndash;Meier curves for overall survival showed no significant differences (Fig.\u0026nbsp;\u003cspan\u003e2\u003c/span\u003e, p\u0026thinsp;=\u0026thinsp;0.172). The mean secondary TRBO was longer in the stent exchange group (128 days) compared to the stent-in-stent group (90 days), though this difference was not statistically significant (p\u0026thinsp;=\u0026thinsp;0.135, \u003cstrong\u003eSupplementary table 3\u003c/strong\u003e). However, Kaplan\u0026ndash;Meier analysis revealed a significant difference in secondary stent patency between the two groups (log-rank p\u0026thinsp;=\u0026thinsp;0.035, \u003cstrong\u003eSupplementary Fig.\u0026nbsp;1\u003c/strong\u003e), indicating a potential advantage of stent exchange over stent-in-stent for prolonged secondary stent patency. The mean overall survival time was 439 days in the stent exchange group and 377 days in the stent-in-stent group, with no statistically significant difference between the two (p\u0026thinsp;=\u0026thinsp;0.325). Kaplan\u0026ndash;Meier survival analysis further confirmed that there was no significant difference in overall survival between the two groups (log-rank p\u0026thinsp;=\u0026thinsp;0.294, \u003cstrong\u003eSupplementary Fig.\u0026nbsp;2\u003c/strong\u003e). Secondary stent outcomes, complication rates, and overall survival were comparable between covered and uncovered SEMS within each revision method (\u003cstrong\u003eSupplementary table 4\u003c/strong\u003e). For the stent exchange group, the median secondary TRBO was 186 days for covered SEMS and 121 days for uncovered SEMS (p\u0026thinsp;=\u0026thinsp;0.265), and 109 days and 102 days, respectively, for the stent-in-stent group (p\u0026thinsp;=\u0026thinsp;0.812). The overall survival was also similar, with 550 days for covered SEMS and 406 days for uncovered SEMS in the stent exchange group (p\u0026thinsp;=\u0026thinsp;0.270), and 314 days and 383 days, respectively, in the stent-in-stent group (p\u0026thinsp;=\u0026thinsp;0.403). These findings indicate that secondary TRBO rates, complication rates, and survival outcomes do not significantly differ between covered and uncovered SEMS within each technique. Kaplan\u0026ndash;Meier survival analysis also revealed no statistically significant differences in primary and secondary stent patency (p\u0026thinsp;=\u0026thinsp;0.782, p\u0026thinsp;=\u0026thinsp;0.498) or overall survival (p\u0026thinsp;=\u0026thinsp;0.654, p\u0026thinsp;=\u0026thinsp;0.276) based on the secondary stent insertion or stent exchange method in the stent-in-stent procedure using covered and uncovered SEMS (\u003cstrong\u003eSupplementary Figs.\u0026nbsp;3\u0026ndash;6\u003c/strong\u003e).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1. Baseline characteristics of patients and clinical outcomes according to the primary and secondary biliary stent type and method\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"619\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eStent exchange, SEMS (covered \u0026amp; uncovered)\u003c/p\u003e\n \u003cp\u003e(n=53)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eStent exchange, plastic stent\u003c/p\u003e\n \u003cp\u003e(n=23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eStent-in-stent, SEMS (covered \u0026amp; uncovered)\u003c/p\u003e\n \u003cp\u003e(n=51)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eStent-in-stent, plastic stent\u003c/p\u003e\n \u003cp\u003e(n=32)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eAge (range) (years)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e71.8 (48\u0026ndash;89)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e70.5 (40\u0026ndash;86)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e69.6 (47\u0026ndash;89)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd\u003e\n \u003cp\u003e67.9 (36\u0026ndash;88)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.323\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eSex\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;Male/female (n)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e26/27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e11/12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29/22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e15/17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.781\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDiagnosis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;Pancreatic cancer, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e33 (62.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e10 (43.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e30 (58.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e19 (59.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.492\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;GB cancer, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2 (3.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3 (13.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (7.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1 (3.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.379\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;CBD cancer, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e13 (24.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e7 (30.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e12 (23.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e9 (28.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.913\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;AOV cancer, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (7.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1 (4.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e3 (5.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2 (6.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.960\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;Metastatic disease, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1 (1.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2 (8.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2 (3.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1 (3.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.556\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTNM stage\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;III, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e23 (43.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e10 (43.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e23 (45.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e17 (53.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.387\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;IV, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e30 (56.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e13 (56.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e28 (54.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e15 (46.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.387\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eDuodenal stricture, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e4 (7.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2 (6.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.139\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eLength of biliary stricture (mm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e26.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e25.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e30.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.265\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eCTx. \u0026plusmn; CCRTx., n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e43 (81.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e16 (69.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e29 (56.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e27 (84.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.149\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTotal bilirubin (mg/dL)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;Baseline\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e7.0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e7.6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e6.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.886\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;Day 1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e5.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.873\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;Day 28\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e1.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e2.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.282\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePrevious procedure, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e17 (32.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e8 (34.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e12 (23.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e8 (25.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e0.663\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAOV, ampulla of vater; CBD, common bile duct; CCRTx., concurrent chemoradiotherapy; CTx., chemotherapy; GB, gallbladder; SEMS, self-expandable metallic stent; TNM, classification of malignant tumors\u003c/p\u003e\n\u003cdiv\u003e\n \u003ctable id=\"Tab1\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 2\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003ePrimary and secondary biliary stent patency and outcomes according to stent type and method\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ccolgroup cols=\"6\"\u003e\u003c/colgroup\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eStent exchange, SEMS (covered \u0026amp; uncovered)\u003c/p\u003e\n \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;53)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eStent exchange, plastic stent\u003c/p\u003e\n \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;23)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eStent-in-stent, SEMS (covered \u0026amp; uncovered)\u003c/p\u003e\n \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;51)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eStent-in-stent, plastic stent\u003c/p\u003e\n \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;32)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003ePrimary stent outcome\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePrimary stent length (cm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6.4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6.2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.605\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePrimary TRBO (day, mean)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e161\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e106\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e154\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e128\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.108\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCause of stent dysfunction\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIngrowth \u0026amp; overgrowth, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (18.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (21.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e30 (58.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e15 (46.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.007\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStone \u0026amp; sludge, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e34 (58.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e9 (39.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e21 (41.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e17 (36.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.068\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMigration, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e12 (22.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e9 (39.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eSecondary stent outcome\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSecondary stent length (cm)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7.1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e7.7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.218\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eSecondary TRBO (day, mean)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e161\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e53\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e104\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e67\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.014\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eEarly complication (\u0026lt;\u0026thinsp;1m)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAcute pancreatitis, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (4.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (3.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.265\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAcute cholangitis, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (7.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (4.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (9.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3 (9.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.870\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMigration, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e2 (3.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (4.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.599\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTotal, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (11.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3 (13.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (9.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (12.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.973\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eLate complication (\u0026ge;\u0026thinsp;1m)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAcute pancreatitis, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (1.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0 (0.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e3 (5.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (3.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.520\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAcute cholangitis, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e29 (54.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e10 (43.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e27 (52.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e19 (59.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.705\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMigration, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e6 (11.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e5 (21.7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e1 (2.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e4 (12.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.060\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eTotal, n (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36 (67.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e15 (65.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e31 (60.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e24 (75.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.606\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eTotal complication, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e42 (79.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e18 (78.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e36 (70.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e28 (87.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.111\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eOverall survival time (day, mean)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e478\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e339\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e337\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e434\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.259\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\"\u003eSEMS, self-expandable metallic stent; TRBO, time to recurrent biliary obstruction\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003ch3\u003eUnivariate and multivariate cox regression analysis\u003c/h3\u003e\n\u003cp\u003eUnivariate and multivariate Cox regression analyses were performed to assess factors influencing secondary TRBO (Table\u0026nbsp;\u003cspan\u003e3\u003c/span\u003e). Univariate analysis indicated that revisions performed within 180 days significantly increased the risk of secondary TRBO (HR: 1.79, 95% CI: 1.13\u0026ndash;2.84, p\u0026thinsp;=\u0026thinsp;0.013). Primary stent malfunction owing to metastasis, rather than tumor growth, was associated with a reduced risk of secondary TRBO (HR: 0.31, 95% CI: 0.13\u0026ndash;0.75, p\u0026thinsp;=\u0026thinsp;0.009). According to the revision method, stent exchange with plastic stents (median TRBO: 53 days) and stent-in-stent with plastic stents (median TRBO: 67 days) were associated with significantly higher risks of secondary TRBO compared to stent exchange with SEMS (HR: 3.62, 95% CI: 1.63\u0026ndash;8.03; HR: 3.58, 95% CI: 1.84\u0026ndash;6.99). Multivariate analysis, accounting for primary TRBO duration, cause of primary stent dysfunction, and cancer type, revealed that shorter primary TRBO (HR: 1.77, 95% CI: 1.10\u0026ndash;2.86), stent migration (HR: 0.30, 95% CI: 0.13\u0026ndash;0.68), and revision method significantly influenced secondary TRBO. Stent exchange with plastic stents had the highest HR for secondary TRBO (HR: 6.84, 95% CI: 2.63\u0026ndash;17.80), followed by stent-in-stent with SEMS (HR: 6.53, 95% CI: 1.89\u0026ndash;22.55) and plastic stents (HR: 2.69, 95% CI: 1.21\u0026ndash;5.97). Cox regression models for overall survival showed no significant differences between revision methods, indicating that the choice of strategy does not directly affect long-term survival outcomes (Table\u0026nbsp;\u003cspan\u003e4\u003c/span\u003e).\u003c/p\u003e\n\u003cdiv\u003e\n \u003ctable id=\"Tab2\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 3\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003eUnivariate and multivariate analysis of variables associated with secondary biliary stent patency\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ccolgroup cols=\"9\"\u003e\u003c/colgroup\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003en\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eMedian\u003c/p\u003e\n \u003cp\u003e(day)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"3\"\u003e\n \u003cp\u003eUnivariate analysis\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"3\"\u003e\n \u003cp\u003eMultivariate analysis\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eHR\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e95% CI\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eHR\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e95% CI\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eDiagnosis\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePancreatic cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e92\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e69\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eGB cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.02\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.37\u0026ndash;2.81\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.976\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.25\u0026ndash;2.08\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.543\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCBD cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e41\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e61\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.70\u0026ndash;1.76\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.657\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.91\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.52\u0026ndash;1.59\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.728\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAoV cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e91\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.09\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.50\u0026ndash;2.40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.828\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.69\u0026ndash;3.86\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.264\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMetastasis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2.90\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.04\u0026ndash;8.13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.043\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.61\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.50\u0026ndash;5.20\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.424\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eTNM stage\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e73\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e65\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.605\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e86\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.71\u0026ndash;1.79\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eLength of biliary stricture\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026ge;\u0026thinsp;25mm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e74\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e69.5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.919\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;25mm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e85\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.98\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.60\u0026ndash;1.60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eCTx.\u003c/strong\u003e \u0026plusmn; \u003cstrong\u003eCCRTx.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e115\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e70\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.148\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e65\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.88\u0026ndash;2.36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eTotal bilirubin (baseline)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026le;\u0026thinsp;3mg/dL\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e66\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e343\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.310\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026gt;\u0026thinsp;3mg/dL\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e93\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e356\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.79\u0026ndash;2.15\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003ePrimary TRBO\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026ge;\u0026thinsp;180days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e47\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e93\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.013\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.019\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;180days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e112\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e67\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.79\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.13\u0026ndash;2.84\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.77\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.10\u0026ndash;2.86\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eCause of primary stent dysfunction\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIngrowth \u0026amp; overgrowth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e55\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStone, sludge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e83\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.69\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.96\u0026ndash;2.99\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.069\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.90\u0026ndash;2.51\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.123\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMigration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e21\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e77\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.31\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.13\u0026ndash;0.75\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.009\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.13\u0026ndash;0.68\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.004\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMethod\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStent exchange, SEMS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e53\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e94\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStent exchange, Plastic stent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e23\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e53\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e3.62\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.63\u0026ndash;8.03\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e6.84\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2.63\u0026ndash;17.8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStent-in-Stent, SEMS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e51\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e75\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.98\u0026ndash;3.02\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.059\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e6.53\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.89\u0026ndash;22.55\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.003\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStent-in-Stent, Plastic stent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e32\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e67\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e3.58\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.84\u0026ndash;6.99\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2.69\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.21\u0026ndash;5.97\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.015\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"9\"\u003eAOV, ampulla of vater; CBD, common bile duct; CCRTx., concurrent chemoradiotherapy; CTx., chemotherapy; GB, gallbladder; SEMS, self-expandable metallic stent; TNM, classification of malignant tumors; TRBO, time to recurrent biliary obstruction\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n\u003c/div\u003e\n\u003cdiv\u003e\n \u003ctable id=\"Tab3\" border=\"1\"\u003e\n \u003ccaption language=\"En\"\u003e\n \u003cdiv\u003eTable 4\u003c/div\u003e\n \u003cdiv\u003e\n \u003cp\u003eUnivariate and multivariate analysis of variables associated with overall survival time\u003c/p\u003e\n \u003c/div\u003e\n \u003c/caption\u003e\n \u003ccolgroup cols=\"9\"\u003e\u003c/colgroup\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003en\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003eMedian\u003c/p\u003e\n \u003cp\u003e(day)\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"3\"\u003e\n \u003cp\u003eUnivariate analysis\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\" colspan=\"3\"\u003e\n \u003cp\u003eMultivariate analysis\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eHR\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e95% CI\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003eHR\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003e95% CI\u003c/p\u003e\n \u003c/th\u003e\n \u003cth align=\"left\"\u003e\n \u003cp\u003ep-value\u003c/p\u003e\n \u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eDiagnosis\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003ePancreatic cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e92\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e348\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eGB cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e173\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.51\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.36\u0026ndash;6.35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.573\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eCBD cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e41\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e334\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.33\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.75\u0026ndash;2.38\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.333\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eAoV cancer\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e546\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.71\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.12\u0026ndash;4.17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.705\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMetastasis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e158\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.64\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.87\u0026ndash;3.10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.129\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eTNM stage\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIII\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e73\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e385\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.079\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.009\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e86\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e333\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.61\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.95\u0026ndash;2.75\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2.26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.23\u0026ndash;4.16\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eLength of biliary stricture\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026ge;\u0026thinsp;25mm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e74\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e342\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.853\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;25mm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e85\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e353\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.93\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.44\u0026ndash;1.97\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eCTx.\u003c/strong\u003e \u0026plusmn; \u003cstrong\u003eCCRTx.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e115\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e362\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.253\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.005\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e253\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.41\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.78\u0026ndash;2.53\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e4.04\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.51\u0026ndash;10.78\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eTotal bilirubin (baseline)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026le;\u0026thinsp;3mg/dL\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e66\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e356\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.050\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.049\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026gt;\u0026thinsp;3mg/dL\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e93\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e324\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.75\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u0026ndash;3.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.755\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u0026ndash;3.07\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003ePrimary TRBO\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026ge;\u0026thinsp;180days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e47\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e474\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.005\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\" rowspan=\"2\"\u003e\n \u003cp\u003e0.019\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u0026lt;\u0026thinsp;180days\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e112\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e280\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e2.46\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.32\u0026ndash;4.60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.77\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.10\u0026ndash;2.86\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eCause of primary stent dysfunction\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eIngrowth \u0026amp; overgrowth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e55\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e294\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStone, sludge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e83\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e338\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.88\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.48\u0026ndash;1.58\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.659\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eMigration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e21\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e385\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.76\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.30\u0026ndash;1.93\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.557\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e\u003cstrong\u003eMethod\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStent exchange, SEMS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e53\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e396\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.00\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eRef.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStent exchange, Plastic stent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e23\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e348\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.80\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.35\u0026ndash;1.83\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.591\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.83\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.31\u0026ndash;2.22\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.704\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStent-in-Stent, SEMS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e51\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e285\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.45\u0026ndash;3.77\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.630\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.41\u0026ndash;4.43\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.625\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003eStent-in-Stent, Plastic stent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e32\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e334\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.59\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.89\u0026ndash;2.86\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.120\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e1.17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"char\"\u003e\n \u003cp\u003e0.58\u0026ndash;2.36\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd align=\"left\"\u003e\n \u003cp\u003e0.658\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003ctfoot\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"9\"\u003eAOV, ampulla of vater; CBD, common bile duct; CCRTx., concurrent chemoradiotherapy; CTx., chemotherapy; GB, gallbladder; SEMS, self-expandable metallic stent; TNM, classification of malignant tumors; TRBO, time to recurrent biliary obstruction\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tfoot\u003e\n \u003c/table\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eOverall the present study demonstrated that, stent replacement with SEMS was more effective in prolonging secondary stent patency compared to stent-in-stent or plastic stents in patients who developed RBO after using FCSEMS as a primary stent for MDBO. Unlike uncovered SEMS, covered SEMS provide greater versatility, including options such as stent removal and reinsertion. This study aimed to compare and analyze differences in secondary TRBO and overall survival across various revision methods among patients with FCSEMS. Overall, we found a significant difference in secondary TRBO among the four groups: stent exchange with SEMS, stent-in-stent with SEMS, stent exchange with plastic stents, and stent-in-stent with plastic stents. Kaplan\u0026ndash;Meier and univariate analyses confirmed the superiority of SEMS over plastic stents, consistent with previous studies\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e,\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e. However, multivariate analysis, incorporating variables from univariate analysis and key clinical factors, demonstrated the superiority of stent exchange with SEMS over stent-in-stent with SEMS in secondary stent patency. While previous studies have reported on the effectiveness of stent-in-stent when metallic primary stents are occluded\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e, this analysis identified that stent exchange is more effective when the primary stent is limited to FCSEMS. Overall survival analysis revealed that the revision methodology did not significantly influence survival duration. Multivariate analysis identified TNM stage, chemotherapy status, and jaundice as critical factors associated with cancer prognosis, thereby highlighting the need to prioritize these factors in cancer management\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e,\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e. Additionally, a significant correlation was found between shorter primary TRBO and decreased survival. Early SEMS occlusion may increase the risk of subsequent occlusion, likely influenced by tumor size, stenosis degree, or location\u003csup\u003e\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e,\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e. Frequent drainage owing to shorter TRBOs can increase risks of further obstruction and cholangitis, ultimately reducing survival\u003csup\u003e\u003cspan additionalcitationids=\"CR20\" citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eAlthough prior studies have reported more frequent cholecystitis and stent migration with covered SEMS\u003csup\u003e\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u003c/sup\u003e, no significant differences in complication rates were observed in this study across procedure methods or SEMS types. These findings indicate that patient clinical characteristics, procedural experience, or recent advances in stent design may have contributed to these results. Further research is thus required to identify risk factors for complications associated with covered SEMS. The results of this study emphasize the efficacy of using FCSEMS as the primary stent for MDBO, followed by stent exchange with SEMS as a revision strategy. A key question raised is the optimal timing for stent exchange. While exchange is clearly indicated when RBO criteria are met or stent dysfunction occurs, the average duration of stent exchange in this study was 4\u0026ndash;5 months, with a range of 18 to 420 days. A thorough assessment of stent function around 4\u0026ndash;5 months may facilitate the early detection of RBO or dysfunction, potentially improving patient outcomes by enabling timely intervention. Additionally, as FCSEMS has demonstrated stent patency for up to 14 months, assessing stent function at 1 year appears to be clinically important. This study faced limitations owing to an imbalance in patient numbers among the groups, with the small sample sizes precluding equalization through propensity score matching. To strengthen these findings, future studies should aim to enroll a larger, more balanced cohort, ideally in a multicenter setting, to enable more robust comparisons. Furthermore, growing interest in partially covered SEMS, which combine features of covered and uncovered stents, warrants investigation\u003csup\u003e\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e,\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e\u003c/sup\u003e. These stents may offer unique advantages and challenges in managing biliary strictures. Follow-up studies should explore the efficacy, safety, and specific indications of various covered SEMS types in clinical practice.\u003c/p\u003e \u003cp\u003eIn conclusion, the present study showed when RBO occurs after initial placement of an FCSEMS for MDBO, stent exchange with SEMS offers an effective alternative, providing superior secondary stent patency without increasing adverse events or negatively impacting overall survival.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eStudy design and patients\u003c/h2\u003e \u003cp\u003eThis multicenter, retrospective study compared the efficacy and safety of various revision methods for RBO following FCSEMS insertion. Patients who underwent ERCP for MBO at one of the three university hospitals between March 2013 and March 2023 were considered eligible. The inclusion criteria included: (1) adults aged\u0026thinsp;\u0026ge;\u0026thinsp;20 years, (2) unresectable MDBO, (3) initial stenting with FCSEMS, and (4) available for follow-up until secondary stent dysfunction. Exclusion criteria included: (1) malignant hilar or intrahepatic duct stricture, (2) initial stent insertion with an uncovered SEMS, (3) loss to follow-up after secondary stenting, (4) percutaneous procedures, (5) endoscopic ultrasound-guided procedures, and (6) contraindications to ERCP, pregnancy, or breastfeeding. The study endpoints were clinical outcomes, complications, and prognoses. A total of 159 patients with MDBO were included, including 76 patients treated with the stent exchange method and 83 with the stent-in-stent method. In the stent exchange group, 53 patients received SEMS and 23 plastic stents, whereas in the stent-in-stent group, 51 patients received SEMS and 32 plastic stents (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eEthics Approval\u003c/h3\u003e\n\u003cp\u003e This study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board (IRB) of Gangnam Severance Hospital (approval number: 3-2022-0248). The requirement for informed consent was waived owing to the retrospective nature of the study. All patient data were anonymized before analysis.\u003c/p\u003e\n\u003ch3\u003eProcedure details and revision techniques\u003c/h3\u003e\n\u003cp\u003eRBO was managed using two revision techniques: (1) stent replacement, involving removal of the existing FCSEMS followed by re-stenting, or (2) stent-in-stent, in which an additional stent was placed without removing the existing FCSEMS. Stents used during reintervention included SEMS (covered or uncovered) and plastic stents. The choice of stent type, length, and diameter was determined by an expert endoscopist, based on the patient\u0026rsquo;s MBO characteristics.\u003c/p\u003e \u003cp\u003eERCP was performed under sedation using diazepam, midazolam, pethidine, and/or propofol, following written informed consent. Duodenoscopes (JF260V or JF290V, Olympus, Tokyo, Japan) were used. The decision to perform balloon sweeping was made by the endoscopist, considering the presence of bile duct sludge or cholangitis.\u003c/p\u003e \u003cp\u003ePlastic stents included Advanix (Boston Scientific, USA) and Zimmon (Cook Medical, USA), with a diameter of 7 Fr and lengths of 5\u0026ndash;8 cm. Commonly used uncovered SEMS included BONASTENT (SEWOON Medical, Korea) and Niti-S D-type (TaeWoong Medical, Korea), while covered SEMS included Hilzo (BCM Co., Korea) and HANAROSTENT (M.I.Tech, Korea). SEMS dimensions ranged from 8 to 10 mm in diameter and 5\u0026ndash;8 cm in length, selected based on stricture length.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eOutcome and definition\u003c/h2\u003e \u003cp\u003eThe primary outcome was secondary stent patency, defined as the TRBO according to the Tokyo criteria: the interval from stent deployment to dysfunction owing to migration, occlusion, or other causes requiring reintervention\u003csup\u003e\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e,\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e\u003c/sup\u003e. Overall survival was defined as the interval from first stent deployment to death. Technical success was defined as successful stent deployment confirmed by imaging. Clinical success was characterized by a\u0026thinsp;\u0026ge;\u0026thinsp;50% reduction in total bilirubin and symptom improvement (e.g., jaundice, abdominal pain, fever) within 1 month\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e. Stent migration was assessed using abdominal radiography or CT, with confirmation performed during follow-up. Stent occlusion was diagnosed radiologically (cholangiography, CT, or MRI) in patients with recurrent cholangitis or jaundice, with causes identified via cholangiography or duodenoscopy. MDBO diagnosis and type were determined using established criteria\u003csup\u003e\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e,\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e\u003c/sup\u003e. The study endpoint was secondary stent occlusion or death. Adverse events were evaluated based on the ESGE guidelines\u003csup\u003e\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u003c/sup\u003e.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eContinuous variables were presented as medians and ranges, and categorical variables as percentages. The Mann\u0026ndash;Whitney U test was used for continuous variables, whereas chi-square or Fisher\u0026rsquo;s exact tests were applied for categorical variables. Kaplan\u0026ndash;Meier analysis and log-rank tests were applied to estimate and compare stent patency and overall survival. Univariate and multivariate Cox proportional hazards regression models were employed to identify factors associated with secondary TRBO and overall survival. Variables with p-values\u0026thinsp;\u0026lt;\u0026thinsp;0.05 in univariate analysis and clinically significant variables were included in multivariate analysis. Statistical significance was set at p\u0026thinsp;\u0026lt;\u0026thinsp;0.05, and all analyses were performed using SPSS version 25.0 and R version 4.2.1.\u003c/p\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no acknowledgements to declare.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualization: S. H. Lee, J. H. Cho; Data curation: S. Y. Lee, S. I. Jang, E. J. Kim, D. K. Lee, H. S. Lee, I. R. Cho, W. H. Paik, J. K. Ryu, S. H. Lee, J. H. Cho; Formal analysis: S. Y. Lee; Funding acquisition: S. H. Lee, J. H. Cho; Investigation: S. H. Lee, J. H. Cho; Methodology: S. Y. Lee, S. H. Lee, J. H. Cho; Software: S. Y. Lee, Y. Seong; Validation: S. H. Lee, J. H. Cho; Visualization: S. Y. Lee, S. H. Lee, J. H. Cho; Writing\u0026mdash;original draft: S. Y. Lee, S. H. Lee, J. H. Cho; Writing\u0026mdash;review \u0026amp; editing: S. Y. Lee, S. I. Jang, E. J. Kim, D. K. Lee, H. S. Lee, I. R. Cho, W. H. Paik, J. K. Ryu, S. H. Lee, J. H. Cho.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was supported by the National Research Foundation of Korea (NRF) grant funded by the Ministry of Science and ICT (MSIT), Korea government (No. NRF-2022R1A2C1009842), and a new faculty research initiation grant from Yonsei University College of Medicine for 2024 (2024-32-0044).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAuthors declare no conflict of interests for this article.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analyzed in this study are available from the corresponding author upon reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eDumonceau, J. 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Endoscopic management of combined malignant biliary and gastric outlet obstruction. \u003cem\u003eDig Endosc\u003c/em\u003e \u003cstrong\u003e29\u003c/strong\u003e, 16-25 (2017).\u003c/li\u003e\n\u003cli\u003eMutignani, M.\u003cem\u003e et al.\u003c/em\u003e Combined endoscopic stent insertion in malignant biliary and duodenal obstruction. \u003cem\u003eEndoscopy\u003c/em\u003e \u003cstrong\u003e39\u003c/strong\u003e, 440-447 (2007).\u003c/li\u003e\n\u003cli\u003eDumonceau, J. M.\u003cem\u003e et al.\u003c/em\u003e ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. \u003cem\u003eEndoscopy\u003c/em\u003e \u003cstrong\u003e52\u003c/strong\u003e, 127-149 (2020).\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Malignant distal biliary obstruction, Recurrent biliary obstruction, Revision method, Stent patency","lastPublishedDoi":"10.21203/rs.3.rs-5930361/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5930361/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eFully covered self-expandable metal stents (FCSEMSs) are widely used in managing malignant distal biliary obstruction (MDBO). However, recurrent biliary obstruction (RBO) has become a significant challenge due to improved patient survival with advanced chemotherapy. This multicenter retrospective cohort study evaluated revision techniques for FCSEMS dysfunction in 159 patients with MDBO initially treated with FCSEMSs. Patients were categorized into four groups based on the revision method: stent exchange with self-expandable metal stents (SEMS, n=53) or plastic stents (n=23), and stent-in-stent placement with SEMS (n=51) or plastic stents (n=32). All procedures achieved 100% technical and clinical success. The primary time to recurrent biliary obstruction (TRBO) showed no significant difference among the groups (mean: 142 days, 95% confidence interval [CI]: 121–164 days). However, secondary TRBO differed significantly (p=0.014): 161 days (SEMS, stent exchange), 53 days (plastic stent, stent exchange), 104 days (SEMS, stent-in-stent), and 67 days (plastic stent, stent-in-stent). Multivariate analysis revealed that stent-in-stent placement with SEMS increased the risk of RBO compared to SEMS stent exchange (hazard ratio [HR]: 6.84, 95% CI: 1.89–22.55, p=0.003). Additionally, revision within 180 days was associated with a higher risk of RBO (HR: 1.77, 95% CI: 1.10–2.86, p=0.019). Overall survival was comparable across all groups. These findings suggest that SEMS stent exchange after FCSEMS removal is an effective revision method for RBO in MDBO, providing improved secondary stent patency without increasing adverse events or affecting overall survival.\u003c/p\u003e","manuscriptTitle":"Efficacy of Fully Covered Self-Expanding Metal Stents Removal versus Stent- in-Stent Techniques in Recurrent Malignant Distal Biliary Obstruction","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-02-18 13:22:41","doi":"10.21203/rs.3.rs-5930361/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-12-08T10:25:03+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-06-30T05:20:02+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-06-19T17:14:59+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"193832906066481441270254952596107800815","date":"2025-06-17T16:55:03+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"120503655939424414089040978334641259324","date":"2025-06-07T06:26:32+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-05-29T14:23:34+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-05-26T12:30:42+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-02-13T15:34:48+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-02-12T12:12:28+00:00","index":"","fulltext":""},{"type":"submitted","content":"Scientific Reports","date":"2025-01-30T12:17:50+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"45d68575-c7be-42e8-b5af-a09187f21111","owner":[],"postedDate":"February 18th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":44298076,"name":"Biological sciences/Cancer/Gastrointestinal cancer"},{"id":44298077,"name":"Biological sciences/Cancer/Gastrointestinal cancer/Biliary tract cancer"},{"id":44298078,"name":"Biological sciences/Cancer/Gastrointestinal cancer/Pancreatic cancer"},{"id":44298079,"name":"Health sciences/Gastroenterology/Gastrointestinal diseases/Biliary tract disease/Bile duct disease"}],"tags":[],"updatedAt":"2026-03-02T16:07:37+00:00","versionOfRecord":{"articleIdentity":"rs-5930361","link":"https://doi.org/10.1038/s41598-026-40409-6","journal":{"identity":"scientific-reports","isVorOnly":false,"title":"Scientific Reports"},"publishedOn":"2026-02-24 15:58:41","publishedOnDateReadable":"February 24th, 2026"},"versionCreatedAt":"2025-02-18 13:22:41","video":"","vorDoi":"10.1038/s41598-026-40409-6","vorDoiUrl":"https://doi.org/10.1038/s41598-026-40409-6","workflowStages":[]},"version":"v1","identity":"rs-5930361","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5930361","identity":"rs-5930361","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}