Safety and efficacy of covered self-expandable metallic stent for choledochojejunal anastomotic stricture: A multi-center retrospective cohort study

Safety and efficacy of covered self-expandable metallic stent for choledochojejunal anastomotic stricture: A multi-center retrospective cohort study | 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 Research Article Safety and efficacy of covered self-expandable metallic stent for choledochojejunal anastomotic stricture: A multi-center retrospective cohort study Yuhei Iwasa, Takuji Iwashita, Keisuke Iwata, Mitsuru Okuno, Kota Shimojo, and 5 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4163176/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 10 You are reading this latest preprint version Abstract Background Benign choledochojejunal anastomotic stricture (CJS) is a complication of pancreaticoduodenectomy and choledochojejunostomy. Typically managed with endoscopic balloon dilatation, CJS has a high recurrence rate. Covered metallic stent (CMS) placement is a potential alternative; however, a comprehensive evaluation is lacking. Objectives The aim of this study was to evaluate the treatment outcomes of CMS placement in patients with CJS. Methods We retrospectively analyzed 46 patients who underwent balloon dilation via endoscopic retrograde cholangiopancreatography using a double-balloon endoscope for CJS between October 2010 and October 2023. The study outcomes included technical and clinical success rates, adverse event rates, choledochojejunal anastomotic stricture recurrence rates, and time to recurrence for balloon dilation and CMS treatment for CJS. Results The technical and clinical success rates were 100% for both treatments. Recurrence of CJS was observed in 35% (14/40) of the patients in the balloon dilation group. The recurrence rate was significantly higher in the balloon dilatation group than in the CMS group (35% vs. 0%, p = 0.006). The time to CJS recurrence was significantly shorter in the balloon dilatation group than in the covered metallic stent group (NR vs. NR, p = 0.03). Conclusion Placement of CMS for treating patients with CJS was demonstrated to be an effective and safe method with a lower recurrence rate than balloon dilation. balloon dilation balloon endoscopy-assisted ERCP choledochojejunal anastomotic stricture covered metallic stent pancreaticoduodenectomy Figures Figure 1 Figure 2 Figure 3 Introduction Choledochojejunal anastomotic stricture (CJS) is a delayed complication of hepatectomies, biliary reconstructions, and pancreaticoduodenectomies (PD). The incidence ranges from 3–12%[ 1 ]. Therapeutic intervention is usually necessary for CJS due to its potential to induce obstructive jaundice, cholangitis, bile duct stones, and liver abscesses. The intricate nature of surgically altered anatomy (SAA) complicates conventional endoscopic retrograde cholangiopancreatography (ERCP)-based treatment and can lead to percutaneous transhepatic biliary drainage (PTBD). However, the development of the double-balloon endoscope (DBE) resulted in a paradigm shift; ERCP-based treatment of patients with SAA[ 2 ] became possible. In recent years, the development of endoscopes and equipment has improved the outcomes of CJS treatment. Balloon techniques are commonly used for mechanical dilation and have strong technical and clinical success rates[ 3 , 4 ]. Nevertheless, balloon dilatation alone was associated with a CJS recurrence rate ranging from 31.1–51%[ 3 – 5 ]. To mitigate recurrence, the placement of covered self-expandable metallic stents (CMS) for CJS treatment has been reported in recent years[ 6 , 7 ]. However, there is a paucity of reports on patients with CJS treated with CMS placement. This study aimed to evaluate the safety and efficacy of CMS in patients with CJS. Methods Study Design This retrospective, multicenter study was conducted at Gifu Municipal Hospital and Gifu University Hospital between October 2010 and October 2023. A comprehensive database analysis was performed that encompassed all ERCP procedures that had used DBE. Patients who met the eligibility criteria were included in this study. These criteria specified individuals who underwent ERCP with DBE for benign CJS, as evidenced by intrahepatic bile duct dilation (> 4 mm) on imaging studies. elevated serum hepato-biliary enzymes (> 1.5 x upper limit), or fever (body temperature > 38℃). Exclusion criteria were CJS resulting from malignancy, follow-up period following initial treatment shorter than six months, or challenges in inserting the DBE into the anastomosis or finding the anastomosis. The study was conducted in accordance with the principles of the Declaration of Helsinki. The study protocol was approved by the Institutional Review Board of each institution. Informed consent was obtained from all participants. Endoscopic Procedure A short-type DBE (EI-580BT; Fujifilm, Tokyo, Japan), with an endoscopic working length of 1550 mm and a channel width of 3.2 mm, was used for all procedures. The procedures were performed under moderate sedation using intravenous midazolam and pentazocine. Upon identification of the anastomosis, biliary wire-loaded cannulation was performed using a straight cannula (MTW ERCP catheter, MTW-Endoskopie Manufaktur, Wesel, Germany) and a 0.025-inch guidewire (VisiGlide 2, Olympus, Tokyo, Japan; M-Through, Asahi Intecc, Aichi, Japan; EndoSelector, Boston Scientific, Tokyo, Japan). After deep biliary cannulation, a contrast agent was injected to assess the morphology of the biliary system. Dilation was carried out with a balloon catheter (Hurricane RX, Boston Scientific, Tokyo, Japan, or REN, Kaneka Medix, Osaka, Japan) positioned just above the CJS. The catheter was inflated for 30–60 seconds and sized between 6–12 mm based on the bile duct diameter. After balloon dilation, either an 8- or 10-mm (according to the bile duct diameter) dumbbell-shaped CMS was employed (M-intraductal, Sewoon Medical Inc., Seoul, Korea). Concurrently, a 7Fr plastic stent (Through-and-Pass; Gadelius Medical, Tokyo, Japan) was placed in the contralateral branch to prevent obstructive cholangitis (Fig. 1 ). The stents were removed approximately three months later. Study Outcomes, Definition, and Statistical Analysis The study outcomes were the technical success rate, clinical success rate, adverse event rate, CJS recurrence rate, time to CJS recurrence following balloon dilation, and CMS placement for CJS. The evaluation was performed on a procedural basis and included initial and subsequent evaluations. Technical success was defined as a successful balloon dilation of the CJS and effective stent placement in the targeted bile duct. Clinical success was defined as symptom improvement within 14 days of treatment. Adverse events related to ERCP and their severity were assessed according to the American Society for Gastrointestinal Endoscopy guidelines[ 8 ]. Categorical or nominal variables were analyzed using Fisher's exact test, whereas continuous variables were compared using the Mann-Whitney U test. The time to CJS recurrence was estimated using the Kaplan-Meier method. Differences were evaluated using the log-rank test, with continuous variables presented as medians and a range of minimum to maximum values. All statistical analyses were conducted using the EZR14 software (version 1.61; Saitama Medical Center, Jichi Medical University, Japan). Results Basic Patient Characteristic ERCP with DBE was performed in 46 patients with CJS. Three patients were excluded: two because of failure of DBE insertion into the anastomosis in two patients and one due to failure to locate the anastomosis. Forty-three patients (29 men; median age, 70 years; range: 51–83) met the eligibility criteria and were included in the study. Surgical reconstruction included PD with modified Child’s reconstruction in 36 patients, PD with other reconstructions in two patients, and biliary reconstruction with Roux-en-Y in five patients. The primary conditions included pancreatic cancer (25 patients), intraductal papillary neoplasm (six patients), cholangiocarcinoma (five patients), and other diseases (seven patients). Clinical symptoms or abnormal laboratory findings included elevated liver enzyme levels (n = 40), fever (n = 31), jaundice (n = 6), and abdominal pain (n = 1), with some cases presenting with overlapping symptoms. The median duration from surgery to the first endoscopic intervention was 329 days (range, 21–3113). Table 1 summarizes the basic patient characteristics. Treatment Outcome of Balloon Dilation and Metallic Stent Placement A flowchart illustrating the patient selection process is shown in Fig. 2 . Initially, 35 patients underwent balloon dilation alone, and 12 patients experienced CJS recurrence. Of these 12 patients, seven underwent CMS placement and five underwent a second balloon dilation, with two of the five patients experiencing further CJS recurrence. Forty balloon dilation procedures were performed, resulting in a 35% recurrence rate (14 recurrences). The technical and clinical success rates for each procedure was 100%, and no adverse events were reported. The median time to CJS recurrence after balloon dilation was 271 days (range: 14–957) (Table 2). Eight patients initially underwent CMS placement and seven underwent CMS placement following balloon dilation treatment, for a total of 15 CMS placements (Table 3 ). The technical and clinical success rates of CMS placement were 100%. The only adverse event observed was non-occlusive cholangitis in one patient, which improved with conservative treatment. To date, no CJS recurrence has been noted in any of the patients (median follow-up, 510 days). Comparison of Treatment Outcomes with Balloon Dilation and Metallic Stent As shown in Table 4 , the technical and clinical success rates for both balloon dilation and CMS placement were 100%, with no significant differences (p = 1). One case of non-occlusive cholangitis was noted in the CMS group; however, this difference was not significant (p = 0.26). The balloon dilation group experienced 14 CJS recurrences (35%), which was significantly higher than in the CMS group, which had no recurrence (p = 0.006). The Kaplan-Meier curve for the time to CJS recurrence indicated a significantly shorter recurrence duration in the balloon dilation group (p = 0.003) (Fig. 3 ). Discussion This study involved 43 patients who underwent 55 procedures (40 balloon dilations and 15 CMS placements) for CJS. The recurrence rate was 35% in the balloon dilation group and 0% in the CMS group. This difference highlights the superior efficacy of CMS implantation in the treatment of CJS. Furthermore, the CMS group experienced only one adverse event (non-occlusive cholangitis), but no significant difference in the rate of adverse events compared with the balloon dilation group, which confirmed the safety of CMS placement. Numerous studies have reported CMS placement for benign biliary strictures, often following cases of unsuccessful balloon dilation or plastic stent placement. Schwartz et al.[ 9 ] noted that balloon dilation alone was ineffective in treating benign biliary strictures, with only 27% of patients showing stricture resolution. Costamagna et al.[ 10 ] demonstrated the utility of multiple plastic stent placements by increasing the number of stents that were inserted until the biliary stricture completely disappeared. The study treated forty-five patients with this technique, which resulted in an 89% stricture resolution rate with no recurrence over a follow-up period of 48.8 months (range 2-11.3 years). Despite the favorable outcomes of multiple plastic stent placements, this method requires numerous procedures and involves complicated stent insertion. To simplify the process, a CMS, which has a significantly larger diameter than plastic stents, was used to manage benign biliary strictures. Tarantino et al.[ 11 ] reported a stricture resolution rate of 90.3% following after 3-month CMS placement in patients with benign biliary strictures. A meta-analysis comparing CMS with multiple plastic stents for benign biliary strictures showed no significant differences in stricture resolution, recurrence, or adverse events rates[ 12 ]. An randomized controlled trial by Cote et al.[ 13 ] hat compared plastic stents and CMS for benign biliary strictures found that fewer ERCP procedures were required with CMS placement (CMS, 2.14 vs. plastic stent, 3.24, p < 0.01). As the treatment outcome is comparable to that of multiple plastic stent implantations and may reduce the number of procedures, the European Society of Gastrointestinal Endoscopy (ESGE) guidelines also strongly recommend CMS placement for benign biliary strictures[ 14 ]. Based on this evidence, CMS is considered an effective and safe treatment modality for benign biliary strictures. In contrast to the extensive literature on CMS for benign biliary strictures, few studies have assessed the efficacy and safety of CMS for CJS. Shibuya et al.[ 7 ] conducted a retrospective study of 29 patients with CJS who were treated endoscopically. Among them, CMS placement using either a 6 mm or 10 mm CMS performed in 13 patients, and this approach yielded 100% (13/13) technical and clinical success rates with no adverse events or recurrences over a median follow-up period of 225 days (range 30–935 days). A retrospective study by Sato et al. [ 6 ]evaluated 20 patients with CJS treated with a 6- or 8-mm diameter dumbbell-type CMS and reported technical success rates of 100% and 85%, an adverse event rate of 7.5%, and stricture resolution with only a 5.8% recurrence rate over a median follow-up of 11.9 months. In our study, 15 patients underwent CMS placement, with 100% technical and clinical success rates and no CJS recurrence. Only one case of non-occlusive cholangitis was managed conservatively. These results suggest that CMS placement is a safe and effective treatment for CJS. However, the indications and duration of CMS placement remain controversial. Patients exhibiting risk factors for CJS recurrence following balloon dilation alone may be suitable candidates. In our previous study[ 3 ], significant risk factors for CJS recurrence in balloon dilation alone were shorter time from surgery to CJS development (Unit Hazard Ratio [95%CI]; 0.87[0.76–0.99], p = 0.04) and residual waist during balloon dilation (Hazard Ratio [95%CI]; 5. 46[1.18–25.1], p = 0.03). Furthermore, other studies have identified risk factors for CJS recurrence after balloon dilation alone. Tomoda et al. reported an increased recurrence in patients who developed CJS within one year after surgery[ 15 ], Sato et al. observed a higher recurrence in patients with a scar-like appearance around the anastomosis[ 6 ], and Sano et al. found a significant recurrence in patients with a residual waist at the time of balloon dilation[ 5 ]. Considering the low CJS recurrence rate associated with CMS placement, this treatment may be the preferred option for the management of high-risk patients with CJS recurrence who have undergone balloon dilation alone. Considering the low CJS recurrence rate of treatment with CMS placement, balloon dilation alone may be a better indication for CMS placement in the aforementioned high-risk patients with CJS recurrence. Extended periods of CMS placement are more likely to facilitate improvements in strictures. However, this may make the removal process more challenging. A meta-analysis focusing on CMS placement for benign bile duct stenosis, excluding cases with CJS, revealed a significant reduction in recurrence rates for durations extending to six months, compared to those of three months or less[ 12 ]. Correspondingly, the ESGE guidelines tentatively suggest a six-month duration for stent placement[ 14 ]. In contrast, our study, along with previous investigations[ 6 , 7 ], observed a CMS placement duration of two to three months. This duration was notably shorter than that recommended for benign bile duct strictures without CJS. Given the absence of reported difficulties in stent removal and favorable outcomes, a two to three-month timeframe for CMS placement appears to be practical and effective. Although CMS placement offers high stricture improvement and low recurrence rates, its disadvantages should also be addressed. First, stent-related complications may have occurred during placement. Sato et al.[ 6 ] observed two instances of spontaneous and asymptomatic stent migration. In our study, one case of nonocclusive cholangitis after CMS placement was recorded, although it was successfully managed. In situations in which CMS placement is deemed unsuitable, the option of placing multiple plastic stent should also be considered[ 16 ]. Secondly, unlike balloon dilatation, which generally requires a single endoscopic procedure in cases with no recurrence, CMS placement requires an additional procedure for stent removal. This is particularly challenging in situations in which repeat endoscopic access to the anastomosis is not feasible, which necessitates careful consideration of CMS placement because of the inability to subsequently remove the stent. In cases DBE insertion into into the anastomosis proves challenging, the endoscopic ultrasound (EUS)-guided approach has recently emerged as a novel method[ 17 ]. This technique involves accessing the biliary system from the upper intestine for drainage or management of biliary diseases[ 18 ]. Although additional evaluations are necessary, the EUS-guided approach may offer a less invasive treatment option since it can be conducted entirely as an internal approach. Another consideration is that the cost of CMS placement may be higher than that of balloon dilation. Given the limited evidence supporting CMS placement in the management of CJS, its use might be reserved for patients who are at high-risk with balloon dilation alone and in cases where stents and scope insertion into the CJS are more easily achievable. Additional research is necessary to gather sufficient evidence for CMS placement alongside balloon dilation in CJS treatment. This study had several limitations. The retrospective design and small cohort size may have introduced selection bias in both the case and treatment choices. The small cohort size also did not allow for statistical analysis, specifically multivariate analysis. Furthermore, the observation period may have been insufficient for a comprehensive evaluation. Additionally, the study was conducted at only two centers, which raises concerns regarding its external validity. CMS placement has emerged as an effective treatment modality for CJS with low recurrence rates. However, all existing reports on CMS placement for CJS, including the present study, were retrospective and involved a limited cohort. Therefore, large-scale prospective studies are required to establish robust evidence. Abbreviations CI, confidence intervals; CJS, choledochojejunal anastomotic stricture; CMS, covered metallic stent; DBE, double balloon endoscopy; ERCP, endoscopic retrograde cholangiopancreatography; PD, pancreaticoduodenectomy; PTBD, percutaneous transhepatic biliary drainage; SAA, surgically altered anatomy; R-Y, Roux-en-Y Declarations Author Contributions: Conceptualization, Y. I. and T. I.; data curation, K. I.; writing—original draft preparation, Y. I. and T. I.; writing—review and editing, Y. I. and T. I.; visualization, M. O., S. U., R. T., S. I., and A. S.; supervision, T. I.; project administration, M. S. All authors have read and agreed to the published version of this manuscript. Funding: None Institutional Review Board Statement: This study was approved by the institutional review boards of Gifu Municipal Hospital (#763) and Gifu University Hospital (#2019-115) before writing this manuscript. Informed Consent Statement: Informed consent was obtained as an option. Data Availability Statement: Not applicable. Conflicts of Interest: The authors declare that they have no conflicts of interest. Acknowledgments : Not applicable. References House MG, Cameron JL, Schulick RDet al. . Incidence and outcome of biliary strictures after pancreaticoduodenectomy Ann Surg . 2006;243:571-576; discussion 576-578; Dimou FM, Adhikari D, Mehta HB, Olino K, Riall TS, Brown KM. Incidence of hepaticojejunostomy stricture after hepaticojejunostomy Surgery . 2016;160:691-698. Yamamoto H, Sekine Y, Sato Yet al. . Total enteroscopy with a nonsurgical steerable double-balloon method Gastrointest Endosc . 2001;53:216-220. Iwasa Y, Iwashita T, Iwata Ket al. . Long- and short-term outcomes of balloon dilation for benign choledochojejunal anastomotic stricture using balloon endoscopy-assisted ERCP: a multi-center retrospective cohort study BMC Gastroenterol . 2023;23:191. Mizukawa S, Tsutsumi K, Kato Het al. . Endoscopic balloon dilatation for benign hepaticojejunostomy anastomotic stricture using short double-balloon enteroscopy in patients with a prior Whipple's procedure: a retrospective study BMC Gastroenterol . 2018;18:14. Sano I, Katanuma A, Kuwatani Met al. . Long-term outcomes after therapeutic endoscopic retrograde cholangiopancreatography using balloon-assisted enteroscopy for anastomotic stenosis of choledochojejunostomy/pancreaticojejunostomy J Gastroenterol Hepatol . 2019;34:612-619. Sato T, Kogure H, Nakai Yet al. . Endoscopic treatment of hepaticojejunostomy anastomotic strictures using fully-covered metal stents Dig Endosc . 2021;33:451-457. Shibuya H, Hara K, Mizuno Net al. . Treatment of biliary strictures with fully covered self-expandable metal stents after pancreaticoduodenectomy Endoscopy . 2017;49:75-79. Cotton PB, Eisen GM, Aabakken Let al. . A lexicon for endoscopic adverse events: report of an ASGE workshop Gastrointest Endosc . 2010;71:446-454. Schwartz DA, Petersen BT, Poterucha JJ, Gostout CJ. Endoscopic therapy of anastomotic bile duct strictures occurring after liver transplantation Gastrointest Endosc . 2000;51:169-174. Costamagna G, Pandolfi M, Mutignani M, Spada C, Perri V. Long-term results of endoscopic management of postoperative bile duct strictures with increasing numbers of stents Gastrointest Endosc . 2001;54:162-168. Tarantino I, Mangiavillano B, Di Mitri Ret al. . Fully covered self-expandable metallic stents in benign biliary strictures: a multicenter study on efficacy and safety Endoscopy . 2012;44:923-927. Khan MA, Baron TH, Kamal Fet al. . Efficacy of self-expandable metal stents in management of benign biliary strictures and comparison with multiple plastic stents: a meta-analysis Endoscopy . 2017;49:682-694. Cote GA, Slivka A, Tarnasky Pet al. . Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial JAMA . 2016;315:1250-1257. Dumonceau JM, Tringali A, Papanikolaou ISet al. . Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017 Endoscopy . 2018;50:910-930. Tomoda T, Kato H, Miyamoto Ket al. . Comparison Between Endoscopic Biliary Stenting Combined with Balloon Dilation and Balloon Dilation Alone for the Treatment of Benign Hepaticojejunostomy Anastomotic Stricture J Gastrointest Surg . 2020;24:1352-1358. Tomoda T, Kato H, Ueki Tet al. . Efficacy of double-balloon enteroscopy-assisted endoscopic balloon dilatation combined with stent deployment for hepaticojejunostomy anastomotic stricture Dig Endosc . 2022;34:604-611. Itonaga M, Kitano M, Ashida R. Development of devices for interventional endoscopic ultrasound for the management of pancreatobiliary diseases Dig Endosc . 2023;35:302-313; Sato T, Nakai Y, Kogure Het al. . ERCP using balloon-assisted endoscopes versus EUS-guided treatment for common bile duct stones in Roux-en-Y gastrectomy Gastrointest Endosc . 2024;99:193-203.e195; Iwashita T, Ogura T, Ishiwatari Het al. . Utility of dedicated bougie dilator for a 0.018-inch guidewire during EUS-guided biliary drainage: A multi-center retrospective cohort study J Hepatobiliary Pancreat Sci . 2022;29:810-816; Iwashita T, Uemura S, Mita Net al. . Endoscopic ultrasound guided-antegrade biliary stenting vs percutaneous transhepatic biliary stenting for unresectable distal malignant biliary obstruction in patients with surgically altered anatomy J Hepatobiliary Pancreat Sci . 2020;27:968-976; Iwashita T, Yasuda I, Mukai Tet al. . Endoscopic ultrasound-guided antegrade biliary stenting for unresectable malignant biliary obstruction in patients with surgically altered anatomy: Single-center prospective pilot study Dig Endosc . 2017;29:362-368; Iwashita T, Doi S, Yasuda I. Endoscopic ultrasound-guided biliary drainage: a review Clin J Gastroenterol . 2014;7:94-102. Iwashita T, Iwasa Y, Senju Aet al. . Comparing endoscopic ultrasound-guided antegrade treatment and balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography in the management of bile duct stones in patients with surgically altered anatomy: A retrospective cohort study J Hepatobiliary Pancreat Sci . 2023; Iwashita T, Uemura S, Tezuka R, Senju A, Yasuda I, Shimizu M. Current status of endoscopic ultrasound-guided antegrade intervention for biliary diseases in patients with surgically altered anatomy Dig Endosc . 2023;35:264-274; Ogura T, Nishioka N, Yamada Met al. . Novel transluminal treatment protocol for hepaticojejunostomy stricture using covered self-expandable metal stent Surg Endosc . 2021;35:209-215. Tables Table 1. Patient characteristics Total number of patients, n 43 Sex (male/female), n 29/14 Age, years, median (range) 70 (51-83) Primary disease, n Pancreatic cancer 25 IPMN 6 Bile duct cancer 5 others 7 Surgical reconstruction, n PD with modified Child 36 PD with others 2 Choledochojejunostomy 5 The median time from surgery to first endoscopic treatment, days, median (range) 329 (21-3113) Clinical symptoms (overlap case), n elevation of liver enzyme 40 fever 31 jaundice 6 abdominal pain 1 IPMN, intraductal papillary mucinous neoplasm; PD, pancreaticoduodenectomy Table 2. Details of treatment with balloon dilation Total number of patients, n 35 Sex (male/female), n 24/11 Age, years, median (range) 71 (51-83) Primary disease, n Pancreatic cancer 19 IPMN 6 Bile duct cancer 4 others 6 Surgical reconstruction, n PD with modified Child 28 PD with others 2 Choledochojejunostomy 5 Total number of sessions, n 40 Balloon diameter, n 6 mm/8 mm/10 mm/11 mm/12 mm 6/24/5/3/2 Technical success, n (%) 40 (100) Adverse event, n (%) 0 (0) Clinical success, n (%) 40 (100) CJS recurrence, n (%) 14 (35) Time to CJS recurrence after balloon dilation, days, median (range) 271 (14-957) Follow up time, days, median (range) 966 (61-3678) IPMN, intraductal papillary mucinous neoplasm; PD, pancreaticoduodenectomy; CJS, choledochojejunal anastomotic stricture Table. 3 Details of treatment with fully-covered self expandable metallic stent Total number of patients, n 15 Sex (male/female), n 9/6 Age, years, median (range) 68 (58-79) Primary disease, n Pancreatic cancer 11 IPMN 1 Bile duct cancer 1 others 2 Surgical reconstruction, n PD with modified Child 15 Total number of sessions, n 15 Previous treatment of balloon dilation, n 7 Stent diameter, 8mm/10mm, n 3/12 Clinical success, n (%) 15 (100) Adverse event, n (%) 1 (6.7) Non-occlusive cholangitis 1 Clinical success, n (%) 15 (100) Indwelling time, days, median (range) 98 (81-175) CJS recurrence, n (%) 0 (0) Follow-up time, days, median (range) 510 (27-1228) IPMN, intraductal papillary mucinous neoplasm; PD, pancreaticoduodenectomy; CJS, choledochojejunal anastomotic stricture Table 4. Comparison of treatment outcome with balloon dilation and metallic stent BD MS p value Total number of patients, n 35 15 - Total number of sessions, n 40 15 - Technical success, n 40 (100) 15 (100) 1 Adverse events, n 0 1 0.27 Non-occlusive cholangitis - 1 - Clinical success, n (%) 40 (100) 15 (100) 1 CJS recurrence, n (%) 14 (35) 0 (0) 0.006 Time to recurrence, days, median (95%CI) NR (422-NR) NR 0.03 CJS, choledochojejunal anastomotic stricture; 95% CI, 95% confidence interval; NR, not reached Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 11 Jun, 2024 Reviews received at journal 11 Jun, 2024 Reviewers agreed at journal 24 May, 2024 Reviews received at journal 16 May, 2024 Reviewers agreed at journal 30 Apr, 2024 Reviewers agreed at journal 29 Apr, 2024 Reviewers invited by journal 07 Apr, 2024 Editor assigned by journal 26 Mar, 2024 Submission checks completed at journal 25 Mar, 2024 First submitted to journal 25 Mar, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4163176","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":284263356,"identity":"d7336a94-1b08-4276-921a-8a950538c121","order_by":0,"name":"Yuhei Iwasa","email":"","orcid":"","institution":"Gifu Municipal Hospital","correspondingAuthor":false,"prefix":"","firstName":"Yuhei","middleName":"","lastName":"Iwasa","suffix":""},{"id":284263358,"identity":"90cad3d8-522e-4f1f-b546-9bf898087e05","order_by":1,"name":"Takuji Iwashita","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA4klEQVRIiWNgGAWjYFACNgYGCQMbBvsDDAYHoEIJeDXwQLSkMTCQpoWB4TBYC3HOsmc/liZhUXA+sbGBeeOBjzsY8vgZGJ49wGsLT9oxCQmD24nNDGwFB2eeYSiWbGBIx2sfD0N6G0hLbhsDj8Fh3jaGxA0HGNIk8Grhfw7Sci63B6ZlP0EtEmCHHcidAbeFgZCWG8+SLSQMkus3MIP80iaROOMwAb+w96cZ3pb4Y2dswN68+cPHNpvE/vaetAf4tIAAM9gdzGA2kMnMk0ZIBwPjBzSbjxHUMgpGwSgYBSMKAAAUZ0Rjqo9bBAAAAABJRU5ErkJggg==","orcid":"","institution":"Gifu University Hospital","correspondingAuthor":true,"prefix":"","firstName":"Takuji","middleName":"","lastName":"Iwashita","suffix":""},{"id":284263360,"identity":"0367d280-2f76-40ea-8b20-20f29ea38487","order_by":2,"name":"Keisuke Iwata","email":"","orcid":"","institution":"Gifu Municipal Hospital","correspondingAuthor":false,"prefix":"","firstName":"Keisuke","middleName":"","lastName":"Iwata","suffix":""},{"id":284263361,"identity":"59d98434-1a90-42f6-b75a-6d5f0543098a","order_by":3,"name":"Mitsuru Okuno","email":"","orcid":"","institution":"Gifu Municipal Hospital","correspondingAuthor":false,"prefix":"","firstName":"Mitsuru","middleName":"","lastName":"Okuno","suffix":""},{"id":284263363,"identity":"a92eb121-b46a-4927-80c0-8b82ca3a3a46","order_by":4,"name":"Kota Shimojo","email":"","orcid":"","institution":"Gifu Municipal Hospital","correspondingAuthor":false,"prefix":"","firstName":"Kota","middleName":"","lastName":"Shimojo","suffix":""},{"id":284263364,"identity":"87757917-50c8-48b1-a934-83b863615a8c","order_by":5,"name":"Shinya Uemura","email":"","orcid":"","institution":"Gifu University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Shinya","middleName":"","lastName":"Uemura","suffix":""},{"id":284263365,"identity":"62ecff76-8016-4c8c-a05a-669d0ed2c068","order_by":6,"name":"Ryuichi Tezuka","email":"","orcid":"","institution":"Gifu University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Ryuichi","middleName":"","lastName":"Tezuka","suffix":""},{"id":284263366,"identity":"c51776b6-4d79-47ad-8ea5-d05e053b274f","order_by":7,"name":"Akihiko Senju","email":"","orcid":"","institution":"Gifu University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Akihiko","middleName":"","lastName":"Senju","suffix":""},{"id":284263367,"identity":"edf8523d-88ad-432a-b92f-db30a2fb4291","order_by":8,"name":"Shota Iwata","email":"","orcid":"","institution":"Gifu University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Shota","middleName":"","lastName":"Iwata","suffix":""},{"id":284263370,"identity":"90c96974-10d7-4d55-ad02-ce7c837c7e10","order_by":9,"name":"Masahito Shimizu","email":"","orcid":"","institution":"Gifu University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Masahito","middleName":"","lastName":"Shimizu","suffix":""}],"badges":[],"createdAt":"2024-03-25 12:16:33","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4163176/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4163176/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":53755950,"identity":"0b8536e4-a28c-41df-a1b3-d16360218a0a","added_by":"auto","created_at":"2024-03-29 19:01:01","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":77816,"visible":true,"origin":"","legend":"\u003cp\u003eFluoroscopic image of a patient undergoing covered metallic stent (CMS) placement. The CMS is accurately positioned within the left hepatic duct (indicated by arrowhead). Concurrently, a plastic stent is strategically inserted into the right hepatic duct (indicated by arrow) as a prophylactic measure against obstructive cholangitis.\u003c/p\u003e","description":"","filename":"Figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4163176/v1/329aa4c4bcaaa9b21a4d3ec8.jpg"},{"id":53757713,"identity":"3671d592-e694-40bb-b75d-f93b8f2b520e","added_by":"auto","created_at":"2024-03-29 19:09:02","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":44173,"visible":true,"origin":"","legend":"\u003cp\u003eFlowchart illustrating the patient selection.\u003c/p\u003e","description":"","filename":"Figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4163176/v1/23046f2f8a54123f7d79a164.jpg"},{"id":53755952,"identity":"8bf732b8-643a-439e-a516-d7067e37f59f","added_by":"auto","created_at":"2024-03-29 19:01:02","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":37028,"visible":true,"origin":"","legend":"\u003cp\u003eKaplan-Meier survival curves depicting the time to choledochojejunostomy anastomosis stricture recurrence.\u003c/p\u003e","description":"","filename":"Figure3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4163176/v1/cd3bea29136de70d3f38c061.jpg"},{"id":53758778,"identity":"a9808464-7411-4497-992e-32f033104e87","added_by":"auto","created_at":"2024-03-29 19:17:02","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":423242,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4163176/v1/05940fcd-7b5b-4f5a-9b59-7da2f863344f.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Safety and efficacy of covered self-expandable metallic stent for choledochojejunal anastomotic stricture: A multi-center retrospective cohort study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eCholedochojejunal anastomotic stricture (CJS) is a delayed complication of hepatectomies, biliary reconstructions, and pancreaticoduodenectomies (PD). The incidence ranges from 3\u0026ndash;12%[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Therapeutic intervention is usually necessary for CJS due to its potential to induce obstructive jaundice, cholangitis, bile duct stones, and liver abscesses. The intricate nature of surgically altered anatomy (SAA) complicates conventional endoscopic retrograde cholangiopancreatography (ERCP)-based treatment and can lead to percutaneous transhepatic biliary drainage (PTBD). However, the development of the double-balloon endoscope (DBE) resulted in a paradigm shift; ERCP-based treatment of patients with SAA[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e] became possible. In recent years, the development of endoscopes and equipment has improved the outcomes of CJS treatment. Balloon techniques are commonly used for mechanical dilation and have strong technical and clinical success rates[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Nevertheless, balloon dilatation alone was associated with a CJS recurrence rate ranging from 31.1\u0026ndash;51%[\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. To mitigate recurrence, the placement of covered self-expandable metallic stents (CMS) for CJS treatment has been reported in recent years[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. However, there is a paucity of reports on patients with CJS treated with CMS placement. This study aimed to evaluate the safety and efficacy of CMS in patients with CJS.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design\u003c/h2\u003e \u003cp\u003eThis retrospective, multicenter study was conducted at Gifu Municipal Hospital and Gifu University Hospital between October 2010 and October 2023. A comprehensive database analysis was performed that encompassed all ERCP procedures that had used DBE. Patients who met the eligibility criteria were included in this study. These criteria specified individuals who underwent ERCP with DBE for benign CJS, as evidenced by intrahepatic bile duct dilation (\u0026gt;\u0026thinsp;4 mm) on imaging studies. elevated serum hepato-biliary enzymes (\u0026gt;\u0026thinsp;1.5 x upper limit), or fever (body temperature\u0026thinsp;\u0026gt;\u0026thinsp;38℃). Exclusion criteria were CJS resulting from malignancy, follow-up period following initial treatment shorter than six months, or challenges in inserting the DBE into the anastomosis or finding the anastomosis. The study was conducted in accordance with the principles of the Declaration of Helsinki. The study protocol was approved by the Institutional Review Board of each institution. Informed consent was obtained from all participants.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eEndoscopic Procedure\u003c/h2\u003e \u003cp\u003eA short-type DBE (EI-580BT; Fujifilm, Tokyo, Japan), with an endoscopic working length of 1550 mm and a channel width of 3.2 mm, was used for all procedures. The procedures were performed under moderate sedation using intravenous midazolam and pentazocine. Upon identification of the anastomosis, biliary wire-loaded cannulation was performed using a straight cannula (MTW ERCP catheter, MTW-Endoskopie Manufaktur, Wesel, Germany) and a 0.025-inch guidewire (VisiGlide 2, Olympus, Tokyo, Japan; M-Through, Asahi Intecc, Aichi, Japan; EndoSelector, Boston Scientific, Tokyo, Japan). After deep biliary cannulation, a contrast agent was injected to assess the morphology of the biliary system. Dilation was carried out with a balloon catheter (Hurricane RX, Boston Scientific, Tokyo, Japan, or REN, Kaneka Medix, Osaka, Japan) positioned just above the CJS. The catheter was inflated for 30\u0026ndash;60 seconds and sized between 6\u0026ndash;12 mm based on the bile duct diameter. After balloon dilation, either an 8- or 10-mm (according to the bile duct diameter) dumbbell-shaped CMS was employed (M-intraductal, Sewoon Medical Inc., Seoul, Korea). Concurrently, a 7Fr plastic stent (Through-and-Pass; Gadelius Medical, Tokyo, Japan) was placed in the contralateral branch to prevent obstructive cholangitis (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e). The stents were removed approximately three months later.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStudy Outcomes, Definition, and Statistical Analysis\u003c/h2\u003e \u003cp\u003eThe study outcomes were the technical success rate, clinical success rate, adverse event rate, CJS recurrence rate, time to CJS recurrence following balloon dilation, and CMS placement for CJS. The evaluation was performed on a procedural basis and included initial and subsequent evaluations. Technical success was defined as a successful balloon dilation of the CJS and effective stent placement in the targeted bile duct. Clinical success was defined as symptom improvement within 14 days of treatment. Adverse events related to ERCP and their severity were assessed according to the American Society for Gastrointestinal Endoscopy guidelines[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Categorical or nominal variables were analyzed using Fisher's exact test, whereas continuous variables were compared using the Mann-Whitney U test. The time to CJS recurrence was estimated using the Kaplan-Meier method. Differences were evaluated using the log-rank test, with continuous variables presented as medians and a range of minimum to maximum values. All statistical analyses were conducted using the EZR14 software (version 1.61; Saitama Medical Center, Jichi Medical University, Japan).\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\n\u003ch2\u003eBasic Patient Characteristic\u003c/h2\u003e\n\u003cp\u003eERCP with DBE was performed in 46 patients with CJS. Three patients were excluded: two because of failure of DBE insertion into the anastomosis in two patients and one due to failure to locate the anastomosis. Forty-three patients (29 men; median age, 70 years; range: 51\u0026ndash;83) met the eligibility criteria and were included in the study. Surgical reconstruction included PD with modified Child\u0026rsquo;s reconstruction in 36 patients, PD with other reconstructions in two patients, and biliary reconstruction with Roux-en-Y in five patients. The primary conditions included pancreatic cancer (25 patients), intraductal papillary neoplasm (six patients), cholangiocarcinoma (five patients), and other diseases (seven patients). Clinical symptoms or abnormal laboratory findings included elevated liver enzyme levels (n\u0026thinsp;=\u0026thinsp;40), fever (n\u0026thinsp;=\u0026thinsp;31), jaundice (n\u0026thinsp;=\u0026thinsp;6), and abdominal pain (n\u0026thinsp;=\u0026thinsp;1), with some cases presenting with overlapping symptoms. The median duration from surgery to the first endoscopic intervention was 329 days (range, 21\u0026ndash;3113). Table\u0026nbsp;1 summarizes the basic patient characteristics.\u003c/p\u003e\n\u003c/div\u003e\n\u003ch2\u003eTreatment Outcome of Balloon Dilation and Metallic Stent Placement\u003c/h2\u003e\n\u003cp\u003eA flowchart illustrating the patient selection process is shown in Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e. Initially, 35 patients underwent balloon dilation alone, and 12 patients experienced CJS recurrence. Of these 12 patients, seven underwent CMS placement and five underwent a second balloon dilation, with two of the five patients experiencing further CJS recurrence. Forty balloon dilation procedures were performed, resulting in a 35% recurrence rate (14 recurrences). The technical and clinical success rates for each procedure was 100%, and no adverse events were reported. The median time to CJS recurrence after balloon dilation was 271 days (range: 14\u0026ndash;957) (Table\u0026nbsp;2). Eight patients initially underwent CMS placement and seven underwent CMS placement following balloon dilation treatment, for a total of 15 CMS placements (Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e). The technical and clinical success rates of CMS placement were 100%. The only adverse event observed was non-occlusive cholangitis in one patient, which improved with conservative treatment. To date, no CJS recurrence has been noted in any of the patients (median follow-up, 510 days).\u003c/p\u003e\n\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n\u003ch2\u003eComparison of Treatment Outcomes with Balloon Dilation and Metallic Stent\u003c/h2\u003e\n\u003cp\u003eAs shown in Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e, the technical and clinical success rates for both balloon dilation and CMS placement were 100%, with no significant differences (p\u0026thinsp;=\u0026thinsp;1). One case of non-occlusive cholangitis was noted in the CMS group; however, this difference was not significant (p\u0026thinsp;=\u0026thinsp;0.26). The balloon dilation group experienced 14 CJS recurrences (35%), which was significantly higher than in the CMS group, which had no recurrence (p\u0026thinsp;=\u0026thinsp;0.006). The Kaplan-Meier curve for the time to CJS recurrence indicated a significantly shorter recurrence duration in the balloon dilation group (p\u0026thinsp;=\u0026thinsp;0.003) (Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study involved 43 patients who underwent 55 procedures (40 balloon dilations and 15 CMS placements) for CJS. The recurrence rate was 35% in the balloon dilation group and 0% in the CMS group. This difference highlights the superior efficacy of CMS implantation in the treatment of CJS. Furthermore, the CMS group experienced only one adverse event (non-occlusive cholangitis), but no significant difference in the rate of adverse events compared with the balloon dilation group, which confirmed the safety of CMS placement.\u003c/p\u003e \u003cp\u003eNumerous studies have reported CMS placement for benign biliary strictures, often following cases of unsuccessful balloon dilation or plastic stent placement. Schwartz et al.[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] noted that balloon dilation alone was ineffective in treating benign biliary strictures, with only 27% of patients showing stricture resolution. Costamagna et al.[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] demonstrated the utility of multiple plastic stent placements by increasing the number of stents that were inserted until the biliary stricture completely disappeared. The study treated forty-five patients with this technique, which resulted in an 89% stricture resolution rate with no recurrence over a follow-up period of 48.8 months (range 2-11.3 years). Despite the favorable outcomes of multiple plastic stent placements, this method requires numerous procedures and involves complicated stent insertion. To simplify the process, a CMS, which has a significantly larger diameter than plastic stents, was used to manage benign biliary strictures. Tarantino et al.[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] reported a stricture resolution rate of 90.3% following after 3-month CMS placement in patients with benign biliary strictures. A meta-analysis comparing CMS with multiple plastic stents for benign biliary strictures showed no significant differences in stricture resolution, recurrence, or adverse events rates[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. An randomized controlled trial by Cote et al.[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] hat compared plastic stents and CMS for benign biliary strictures found that fewer ERCP procedures were required with CMS placement (CMS, 2.14 vs. plastic stent, 3.24, p\u0026thinsp;\u0026lt;\u0026thinsp;0.01). As the treatment outcome is comparable to that of multiple plastic stent implantations and may reduce the number of procedures, the European Society of Gastrointestinal Endoscopy (ESGE) guidelines also strongly recommend CMS placement for benign biliary strictures[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Based on this evidence, CMS is considered an effective and safe treatment modality for benign biliary strictures.\u003c/p\u003e \u003cp\u003eIn contrast to the extensive literature on CMS for benign biliary strictures, few studies have assessed the efficacy and safety of CMS for CJS. Shibuya et al.[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] conducted a retrospective study of 29 patients with CJS who were treated endoscopically. Among them, CMS placement using either a 6 mm or 10 mm CMS performed in 13 patients, and this approach yielded 100% (13/13) technical and clinical success rates with no adverse events or recurrences over a median follow-up period of 225 days (range 30\u0026ndash;935 days). A retrospective study by Sato et al. [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]evaluated 20 patients with CJS treated with a 6- or 8-mm diameter dumbbell-type CMS and reported technical success rates of 100% and 85%, an adverse event rate of 7.5%, and stricture resolution with only a 5.8% recurrence rate over a median follow-up of 11.9 months. In our study, 15 patients underwent CMS placement, with 100% technical and clinical success rates and no CJS recurrence. Only one case of non-occlusive cholangitis was managed conservatively. These results suggest that CMS placement is a safe and effective treatment for CJS. However, the indications and duration of CMS placement remain controversial.\u003c/p\u003e \u003cp\u003ePatients exhibiting risk factors for CJS recurrence following balloon dilation alone may be suitable candidates. In our previous study[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e], significant risk factors for CJS recurrence in balloon dilation alone were shorter time from surgery to CJS development (Unit Hazard Ratio [95%CI]; 0.87[0.76\u0026ndash;0.99], p\u0026thinsp;=\u0026thinsp;0.04) and residual waist during balloon dilation (Hazard Ratio [95%CI]; 5. 46[1.18\u0026ndash;25.1], p\u0026thinsp;=\u0026thinsp;0.03). Furthermore, other studies have identified risk factors for CJS recurrence after balloon dilation alone. Tomoda et al. reported an increased recurrence in patients who developed CJS within one year after surgery[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], Sato et al. observed a higher recurrence in patients with a scar-like appearance around the anastomosis[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e], and Sano et al. found a significant recurrence in patients with a residual waist at the time of balloon dilation[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Considering the low CJS recurrence rate associated with CMS placement, this treatment may be the preferred option for the management of high-risk patients with CJS recurrence who have undergone balloon dilation alone. Considering the low CJS recurrence rate of treatment with CMS placement, balloon dilation alone may be a better indication for CMS placement in the aforementioned high-risk patients with CJS recurrence.\u003c/p\u003e \u003cp\u003eExtended periods of CMS placement are more likely to facilitate improvements in strictures. However, this may make the removal process more challenging. A meta-analysis focusing on CMS placement for benign bile duct stenosis, excluding cases with CJS, revealed a significant reduction in recurrence rates for durations extending to six months, compared to those of three months or less[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Correspondingly, the ESGE guidelines tentatively suggest a six-month duration for stent placement[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. In contrast, our study, along with previous investigations[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e], observed a CMS placement duration of two to three months. This duration was notably shorter than that recommended for benign bile duct strictures without CJS. Given the absence of reported difficulties in stent removal and favorable outcomes, a two to three-month timeframe for CMS placement appears to be practical and effective.\u003c/p\u003e \u003cp\u003eAlthough CMS placement offers high stricture improvement and low recurrence rates, its disadvantages should also be addressed. First, stent-related complications may have occurred during placement. Sato et al.[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] observed two instances of spontaneous and asymptomatic stent migration. In our study, one case of nonocclusive cholangitis after CMS placement was recorded, although it was successfully managed. In situations in which CMS placement is deemed unsuitable, the option of placing multiple plastic stent should also be considered[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Secondly, unlike balloon dilatation, which generally requires a single endoscopic procedure in cases with no recurrence, CMS placement requires an additional procedure for stent removal. This is particularly challenging in situations in which repeat endoscopic access to the anastomosis is not feasible, which necessitates careful consideration of CMS placement because of the inability to subsequently remove the stent. In cases DBE insertion into into the anastomosis proves challenging, the endoscopic ultrasound (EUS)-guided approach has recently emerged as a novel method[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. This technique involves accessing the biliary system from the upper intestine for drainage or management of biliary diseases[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Although additional evaluations are necessary, the EUS-guided approach may offer a less invasive treatment option since it can be conducted entirely as an internal approach. Another consideration is that the cost of CMS placement may be higher than that of balloon dilation. Given the limited evidence supporting CMS placement in the management of CJS, its use might be reserved for patients who are at high-risk with balloon dilation alone and in cases where stents and scope insertion into the CJS are more easily achievable. Additional research is necessary to gather sufficient evidence for CMS placement alongside balloon dilation in CJS treatment.\u003c/p\u003e \u003cp\u003eThis study had several limitations. The retrospective design and small cohort size may have introduced selection bias in both the case and treatment choices. The small cohort size also did not allow for statistical analysis, specifically multivariate analysis. Furthermore, the observation period may have been insufficient for a comprehensive evaluation. Additionally, the study was conducted at only two centers, which raises concerns regarding its external validity.\u003c/p\u003e \u003cp\u003eCMS placement has emerged as an effective treatment modality for CJS with low recurrence rates. However, all existing reports on CMS placement for CJS, including the present study, were retrospective and involved a limited cohort. Therefore, large-scale prospective studies are required to establish robust evidence.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCI, confidence intervals; CJS, choledochojejunal anastomotic stricture; CMS, covered metallic stent; DBE, double balloon endoscopy; ERCP, endoscopic retrograde cholangiopancreatography; PD, pancreaticoduodenectomy; PTBD, percutaneous transhepatic biliary drainage; SAA, surgically altered anatomy; R-Y, Roux-en-Y\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthor Contributions:\u0026nbsp;\u003c/strong\u003eConceptualization, Y. I. and T. I.; data curation, K. I.; writing\u0026mdash;original draft preparation, Y. I. and T. I.; writing\u0026mdash;review and editing, Y. I. and T. I.; visualization, M. O., S. U., R. T., S. I., and A. S.; supervision, T. I.; project administration, M. S. All authors have read and agreed to the published version of this manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eNone\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInstitutional Review Board Statement:\u0026nbsp;\u003c/strong\u003eThis study was approved by the institutional review boards of Gifu Municipal Hospital (#763) and Gifu University Hospital (#2019-115) before writing this manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInformed Consent Statement:\u0026nbsp;\u003c/strong\u003eInformed consent was obtained as an option.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability Statement:\u003c/strong\u003e Not applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflicts of Interest:\u0026nbsp;\u003c/strong\u003eThe authors declare that they have no conflicts of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e: Not applicable.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eHouse MG, Cameron JL, Schulick RDet al. . Incidence and outcome of biliary strictures after pancreaticoduodenectomy \u003cem\u003eAnn Surg\u003c/em\u003e. 2006;243:571-576; discussion 576-578; Dimou FM, Adhikari D, Mehta HB, Olino K, Riall TS, Brown KM. Incidence of hepaticojejunostomy stricture after hepaticojejunostomy \u003cem\u003eSurgery\u003c/em\u003e. 2016;160:691-698.\u003c/li\u003e\n \u003cli\u003eYamamoto H, Sekine Y, Sato Yet al. . Total enteroscopy with a nonsurgical steerable double-balloon method \u003cem\u003eGastrointest Endosc\u003c/em\u003e. 2001;53:216-220.\u003c/li\u003e\n \u003cli\u003eIwasa Y, Iwashita T, Iwata Ket al. . Long- and short-term outcomes of balloon dilation for benign choledochojejunal anastomotic stricture using balloon endoscopy-assisted ERCP: a multi-center retrospective cohort study \u003cem\u003eBMC Gastroenterol\u003c/em\u003e. 2023;23:191.\u003c/li\u003e\n \u003cli\u003eMizukawa S, Tsutsumi K, Kato Het al. . Endoscopic balloon dilatation for benign hepaticojejunostomy anastomotic stricture using short double-balloon enteroscopy in patients with a prior Whipple\u0026apos;s procedure: a retrospective study \u003cem\u003eBMC Gastroenterol\u003c/em\u003e. 2018;18:14.\u003c/li\u003e\n \u003cli\u003eSano I, Katanuma A, Kuwatani Met al. . Long-term outcomes after therapeutic endoscopic retrograde cholangiopancreatography using balloon-assisted enteroscopy for anastomotic stenosis of choledochojejunostomy/pancreaticojejunostomy \u003cem\u003eJ Gastroenterol Hepatol\u003c/em\u003e. 2019;34:612-619.\u003c/li\u003e\n \u003cli\u003eSato T, Kogure H, Nakai Yet al. . Endoscopic treatment of hepaticojejunostomy anastomotic strictures using fully-covered metal stents \u003cem\u003eDig Endosc\u003c/em\u003e. 2021;33:451-457.\u003c/li\u003e\n \u003cli\u003eShibuya H, Hara K, Mizuno Net al. . Treatment of biliary strictures with fully covered self-expandable metal stents after pancreaticoduodenectomy \u003cem\u003eEndoscopy\u003c/em\u003e. 2017;49:75-79.\u003c/li\u003e\n \u003cli\u003eCotton PB, Eisen GM, Aabakken Let al. . A lexicon for endoscopic adverse events: report of an ASGE workshop \u003cem\u003eGastrointest Endosc\u003c/em\u003e. 2010;71:446-454.\u003c/li\u003e\n \u003cli\u003eSchwartz DA, Petersen BT, Poterucha JJ, Gostout CJ. Endoscopic therapy of anastomotic bile duct strictures occurring after liver transplantation \u003cem\u003eGastrointest Endosc\u003c/em\u003e. 2000;51:169-174.\u003c/li\u003e\n \u003cli\u003eCostamagna G, Pandolfi M, Mutignani M, Spada C, Perri V. Long-term results of endoscopic management of postoperative bile duct strictures with increasing numbers of stents \u003cem\u003eGastrointest Endosc\u003c/em\u003e. 2001;54:162-168.\u003c/li\u003e\n \u003cli\u003eTarantino I, Mangiavillano B, Di Mitri Ret al. . Fully covered self-expandable metallic stents in benign biliary strictures: a multicenter study on efficacy and safety \u003cem\u003eEndoscopy\u003c/em\u003e. 2012;44:923-927.\u003c/li\u003e\n \u003cli\u003eKhan MA, Baron TH, Kamal Fet al. . Efficacy of self-expandable metal stents in management of benign biliary strictures and comparison with multiple plastic stents: a meta-analysis \u003cem\u003eEndoscopy\u003c/em\u003e. 2017;49:682-694.\u003c/li\u003e\n \u003cli\u003eCote GA, Slivka A, Tarnasky Pet al. . Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial \u003cem\u003eJAMA\u003c/em\u003e. 2016;315:1250-1257.\u003c/li\u003e\n \u003cli\u003eDumonceau JM, Tringali A, Papanikolaou ISet al. . Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017 \u003cem\u003eEndoscopy\u003c/em\u003e. 2018;50:910-930.\u003c/li\u003e\n \u003cli\u003eTomoda T, Kato H, Miyamoto Ket al. . Comparison Between Endoscopic Biliary Stenting Combined with Balloon Dilation and Balloon Dilation Alone for the Treatment of Benign Hepaticojejunostomy Anastomotic Stricture \u003cem\u003eJ Gastrointest Surg\u003c/em\u003e. 2020;24:1352-1358.\u003c/li\u003e\n \u003cli\u003eTomoda T, Kato H, Ueki Tet al. . Efficacy of double-balloon enteroscopy-assisted endoscopic balloon dilatation combined with stent deployment for hepaticojejunostomy anastomotic stricture \u003cem\u003eDig Endosc\u003c/em\u003e. 2022;34:604-611.\u003c/li\u003e\n \u003cli\u003eItonaga M, Kitano M, Ashida R. Development of devices for interventional endoscopic ultrasound for the management of pancreatobiliary diseases \u003cem\u003eDig Endosc\u003c/em\u003e. 2023;35:302-313; Sato T, Nakai Y, Kogure Het al. . ERCP using balloon-assisted endoscopes versus EUS-guided treatment for common bile duct stones in Roux-en-Y gastrectomy \u003cem\u003eGastrointest Endosc\u003c/em\u003e. 2024;99:193-203.e195; Iwashita T, Ogura T, Ishiwatari Het al. . Utility of dedicated bougie dilator for a 0.018-inch guidewire during EUS-guided biliary drainage: A multi-center retrospective cohort study \u003cem\u003eJ Hepatobiliary Pancreat Sci\u003c/em\u003e. 2022;29:810-816; Iwashita T, Uemura S, Mita Net al. . Endoscopic ultrasound guided-antegrade biliary stenting vs percutaneous transhepatic biliary stenting for unresectable distal malignant biliary obstruction in patients with surgically altered anatomy \u003cem\u003eJ Hepatobiliary Pancreat Sci\u003c/em\u003e. 2020;27:968-976; Iwashita T, Yasuda I, Mukai Tet al. . Endoscopic ultrasound-guided antegrade biliary stenting for unresectable malignant biliary obstruction in patients with surgically altered anatomy: Single-center prospective pilot study \u003cem\u003eDig Endosc\u003c/em\u003e. 2017;29:362-368; Iwashita T, Doi S, Yasuda I. Endoscopic ultrasound-guided biliary drainage: a review \u003cem\u003eClin J Gastroenterol\u003c/em\u003e. 2014;7:94-102.\u003c/li\u003e\n \u003cli\u003eIwashita T, Iwasa Y, Senju Aet al. . Comparing endoscopic ultrasound-guided antegrade treatment and balloon endoscopy-assisted endoscopic retrograde cholangiopancreatography in the management of bile duct stones in patients with surgically altered anatomy: A retrospective cohort study \u003cem\u003eJ Hepatobiliary Pancreat Sci\u003c/em\u003e. 2023; Iwashita T, Uemura S, Tezuka R, Senju A, Yasuda I, Shimizu M. Current status of endoscopic ultrasound-guided antegrade intervention for biliary diseases in patients with surgically altered anatomy \u003cem\u003eDig Endosc\u003c/em\u003e. 2023;35:264-274; Ogura T, Nishioka N, Yamada Met al. . Novel transluminal treatment protocol for hepaticojejunostomy stricture using covered self-expandable metal stent \u003cem\u003eSurg Endosc\u003c/em\u003e. 2021;35:209-215.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1. Patient characteristics\u003c/p\u003e\n\u003ctable border=\"1\" width=\"419\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eTotal number of patients, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e43\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eSex (male/female), n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e29/14\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eAge, years, median (range)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e70 (51-83)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003ePrimary disease, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003ePancreatic cancer\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e25\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eIPMN\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eBile duct cancer\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eothers\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eSurgical reconstruction, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003ePD with modified Child\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e36\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003ePD with others\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eCholedochojejunostomy\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e5\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eThe median time from surgery to first endoscopic treatment, days, median (range)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e329 (21-3113)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.59904534606206%\"\u003e\n\u003cp\u003eClinical symptoms (overlap case), n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eelevation of liver enzyme\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e40\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003efever\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e31\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003ejaundice\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"50.83532219570406%\"\u003e\n\u003cp\u003eabdominal pain\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"28.400954653937948%\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eIPMN, intraductal papillary mucinous neoplasm; PD, pancreaticoduodenectomy\u003c/p\u003e\n\u003cp\u003eTable 2. Details of treatment with balloon dilation\u003c/p\u003e\n\u003ctable border=\"1\" width=\"440\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eTotal number of patients, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e35\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eSex (male/female), n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e24/11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eAge, years, median (range)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e71 (51-83)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003ePrimary disease, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003ePancreatic cancer\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e19\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eIPMN\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e6\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eBile duct cancer\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e4\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eothers\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e6\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eSurgical reconstruction, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003ePD with modified Child\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e28\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003ePD with others\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e2\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eCholedochojejunostomy\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e5\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eTotal number of sessions, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e40\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eBalloon diameter, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003e6 mm/8 mm/10 mm/11 mm/12 mm\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e6/24/5/3/2\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eTechnical success, n (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e40 (100)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eAdverse event, n (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e0 (0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eClinical success, n (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e40 (100)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eCJS recurrence, n (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e14 (35)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eTime to CJS recurrence\u0026nbsp;\u003cbr /\u003e\u0026nbsp;after balloon dilation, days, median (range)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e271 (14-957)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd style=\"width: 71.8987%;\" width=\"64.77272727272727%\"\u003e\n\u003cp\u003eFollow up time, days, median (range)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd style=\"width: 28.1013%;\" width=\"25.227272727272727%\"\u003e\n\u003cp\u003e966 (61-3678)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eIPMN, intraductal papillary mucinous neoplasm; PD, pancreaticoduodenectomy; CJS, choledochojejunal anastomotic stricture\u003c/p\u003e\n\u003cp\u003eTable. 3 Details of treatment with fully-covered self expandable metallic stent\u003c/p\u003e\n\u003ctable border=\"1\" width=\"481\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eTotal number of patients, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e15\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eSex (male/female), n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e9/6\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eAge, years, median (range)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e68 (58-79)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003ePrimary disease, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003ePancreatic cancer\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e11\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eIPMN\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eBile duct cancer\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eothers\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e2\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eSurgical reconstruction, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003ePD with modified Child\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e15\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eTotal number of sessions, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e15\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003ePrevious treatment of balloon dilation, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e7\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eStent diameter, 8mm/10mm, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e3/12\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eClinical success, n (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e15 (100)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eAdverse event, n (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e1 (6.7)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003e\u0026nbsp; Non-occlusive cholangitis\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eClinical success, n (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e15 (100)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eIndwelling time, days, median (range)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e98 (81-175)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eCJS recurrence, n (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e0 (0)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"71.3097713097713%\"\u003e\n\u003cp\u003eFollow-up time, days, median (range)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"25.77962577962578%\"\u003e\n\u003cp\u003e510 (27-1228)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eIPMN, intraductal papillary mucinous neoplasm; PD, pancreaticoduodenectomy; CJS, choledochojejunal anastomotic stricture\u003c/p\u003e\n\u003cp\u003eTable 4. Comparison of treatment outcome with balloon dilation and metallic stent\u003c/p\u003e\n\u003ctable border=\"1\" width=\"572\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd width=\"58.56643356643357%\"\u003e\n\u003cp\u003e \u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18.88111888111888%\"\u003e\n\u003cp\u003eBD\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"12.062937062937063%\"\u003e\n\u003cp\u003eMS\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"10.48951048951049%\"\u003e\n\u003cp\u003ep value\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"58.56643356643357%\"\u003e\n\u003cp\u003eTotal number of patients, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18.88111888111888%\"\u003e\n\u003cp\u003e35\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"12.062937062937063%\"\u003e\n\u003cp\u003e15\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"10.48951048951049%\"\u003e\n\u003cp\u003e-\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"58.56643356643357%\"\u003e\n\u003cp\u003eTotal number of sessions, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18.88111888111888%\"\u003e\n\u003cp\u003e40\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"12.062937062937063%\"\u003e\n\u003cp\u003e15\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"10.48951048951049%\"\u003e\n\u003cp\u003e-\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"58.56643356643357%\"\u003e\n\u003cp\u003eTechnical success, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18.88111888111888%\"\u003e\n\u003cp\u003e40 (100)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"12.062937062937063%\"\u003e\n\u003cp\u003e15 (100)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"10.48951048951049%\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"58.56643356643357%\"\u003e\n\u003cp\u003eAdverse events, n\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18.88111888111888%\"\u003e\n\u003cp\u003e0\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"12.062937062937063%\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"10.48951048951049%\"\u003e\n\u003cp\u003e0.27\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"58.56643356643357%\"\u003e\n\u003cp\u003eNon-occlusive cholangitis\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18.88111888111888%\"\u003e\n\u003cp\u003e-\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"12.062937062937063%\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"10.48951048951049%\"\u003e\n\u003cp\u003e-\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"58.56643356643357%\"\u003e\n\u003cp\u003eClinical success, n (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18.88111888111888%\"\u003e\n\u003cp\u003e40 (100)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"12.062937062937063%\"\u003e\n\u003cp\u003e15 (100)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"10.48951048951049%\"\u003e\n\u003cp\u003e1\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"58.56643356643357%\"\u003e\n\u003cp\u003eCJS recurrence, n (%)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18.88111888111888%\"\u003e\n\u003cp\u003e14 (35)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"12.062937062937063%\"\u003e\n\u003cp\u003e0 (0)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"10.48951048951049%\"\u003e\n\u003cp\u003e0.006\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd width=\"58.56643356643357%\"\u003e\n\u003cp\u003eTime to recurrence, days, median (95%CI)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"18.88111888111888%\"\u003e\n\u003cp\u003eNR (422-NR)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"12.062937062937063%\"\u003e\n\u003cp\u003eNR\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd width=\"10.48951048951049%\"\u003e\n\u003cp\u003e0.03\u0026nbsp;\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eCJS, choledochojejunal anastomotic stricture; 95% CI, 95% confidence interval; NR, not reached\u003c/p\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":"digestive-diseases-and-sciences","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ddsj","sideBox":"Learn more about [Digestive Diseases and Sciences](http://link.springer.com/journal/10620)","snPcode":"10620","submissionUrl":"https://submission.nature.com/new-submission/10620/3","title":"Digestive Diseases and Sciences","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"balloon dilation, balloon endoscopy-assisted ERCP, choledochojejunal anastomotic stricture, covered metallic stent, pancreaticoduodenectomy","lastPublishedDoi":"10.21203/rs.3.rs-4163176/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4163176/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eBenign choledochojejunal anastomotic stricture (CJS) is a complication of pancreaticoduodenectomy and choledochojejunostomy. Typically managed with endoscopic balloon dilatation, CJS has a high recurrence rate. Covered metallic stent (CMS) placement is a potential alternative; however, a comprehensive evaluation is lacking.\u003c/p\u003e\u003ch2\u003eObjectives\u003c/h2\u003e \u003cp\u003eThe aim of this study was to evaluate the treatment outcomes of CMS placement in patients with CJS.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eWe retrospectively analyzed 46 patients who underwent balloon dilation via endoscopic retrograde cholangiopancreatography using a double-balloon endoscope for CJS between October 2010 and October 2023. The study outcomes included technical and clinical success rates, adverse event rates, choledochojejunal anastomotic stricture recurrence rates, and time to recurrence for balloon dilation and CMS treatment for CJS.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe technical and clinical success rates were 100% for both treatments. Recurrence of CJS was observed in 35% (14/40) of the patients in the balloon dilation group. The recurrence rate was significantly higher in the balloon dilatation group than in the CMS group (35% vs. 0%, p\u0026thinsp;=\u0026thinsp;0.006). The time to CJS recurrence was significantly shorter in the balloon dilatation group than in the covered metallic stent group (NR vs. NR, p\u0026thinsp;=\u0026thinsp;0.03).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003ePlacement of CMS for treating patients with CJS was demonstrated to be an effective and safe method with a lower recurrence rate than balloon dilation.\u003c/p\u003e","manuscriptTitle":"Safety and efficacy of covered self-expandable metallic stent for choledochojejunal anastomotic stricture: A multi-center retrospective cohort study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-03-29 19:00:57","doi":"10.21203/rs.3.rs-4163176/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-06-11T23:34:59+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-06-11T19:36:06+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"338823536056985447781090732750092080249","date":"2024-05-24T15:33:33+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-05-17T02:08:10+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"320059866932527492644804227687052531728","date":"2024-04-30T16:01:08+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"244267643825994155149107812195492175996","date":"2024-04-29T05:27:45+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-04-08T00:38:44+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-03-26T21:19:00+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-03-25T14:22:16+00:00","index":"","fulltext":""},{"type":"submitted","content":"Digestive Diseases and Sciences","date":"2024-03-25T12:15:24+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"digestive-diseases-and-sciences","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ddsj","sideBox":"Learn more about [Digestive Diseases and Sciences](http://link.springer.com/journal/10620)","snPcode":"10620","submissionUrl":"https://submission.nature.com/new-submission/10620/3","title":"Digestive Diseases and Sciences","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"fc1db832-b445-4a52-bd40-4d91225ab169","owner":[],"postedDate":"March 29th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2024-07-05T13:33:08+00:00","versionOfRecord":[],"versionCreatedAt":"2024-03-29 19:00:57","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4163176","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4163176","identity":"rs-4163176","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}