Inflauence of elective endoscopic transpapillary gallbladder drainage on the management of acute cholecystitis: A retrospective study

Inflauence of elective endoscopic transpapillary gallbladder drainage on the management of acute cholecystitis: A retrospective 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 Inflauence of elective endoscopic transpapillary gallbladder drainage on the management of acute cholecystitis: A retrospective study Fumitaka Niiya, Naoki Tamai, Masataka Yamawaki, Jun Noda, Tetsushi Azami, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6049580/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 01 Jul, 2025 Read the published version in BMC Gastroenterology → Version 1 posted 8 You are reading this latest preprint version Abstract Background Endoscopic transpapillary gallbladder drainage (ETGBD) is used for managing acute cholecystitis (AC) in patients contraindicated for surgery; however, ETGBD is considered challenging, has comparatively lower success rates, and is associated with severe adverse events (AEs). Only a few studies have examined the procedural and anatomical factors affecting technical ETGBD success. This study identified predictive factors for ETGBD in AC to improve success rates and minimize AEs. Methods This study assessed patients treated with ETGBD for AC. Factors associated with technical failure were analyzed based on interval from symptom onset to ETGBD, presence of cystic duct stones, and cystic duct diameter. Results Among 68 patients, the technical success and AE rates were 64.7% and 19.1%, respectively (cystic duct perforation, 8.8%; pancreatitis, 5.9%). Multivariate analysis revealed that early ETGBD and stone impaction in the cystic duct were significant factors associated with technical ETGBD failure. Subgroup analysis demonstrated that early ETGBD was associated with a significantly higher risk of cystic duct perforation and a lower success rate than delayed intervention. Thus, elective ETGBD may enhance procedural success, reducing the risk of cystic duct perforation. Conclusion Elective ETGBD may be considered in cases where ETGBD is anticipated to be challenging. Acute cholecystitis Endoscopic transpapillary gallbladder drainage Laparoscopic cholecystectomy Postoperative adverse events Figures Figure 1 Figure 2 Background Laparoscopic cholecystectomy is an established standard treatment for acute cholecystitis (AC) [1-3]. However, in some patients, surgical intervention may be contraindicated owing to the presence of comorbid conditions. In such patients, nonsurgical options for gallbladder drainage, such as percutaneous transhepatic gallbladder drainage (PTGBD), percutaneous transhepatic gallbladder aspiration (PTGBA), endoscopic transpapillary gallbladder drainage (ETGBD), and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), can be used to decompress the gallbladder effectively. The revised 2018 Tokyo Guidelines recommend PTGBD as the primary nonsurgical alternative for the management of AC [2]. However, significant recurrence rates of cholecystitis (22–47%) have been reported in patients who do not undergo cholecystectomy after the removal of the percutaneous catheter [4,5]. Therefore, the use of ETGBD as an internal stent is an important treatment approach. ETGBD is a method used for gallbladder drainage in the treatment of AC [6-9]. However, ETGBD is considerably challenging to perform, with reported success rates ranging between 64% and 100% [10]. Moreover, there is a risk of adverse events (AEs) related to endoscopic retrograde cholangiopancreatography (ERCP), as well as the likelihood of perforation of the cystic duct during the ETGBD procedure. Therefore, determining how to increase the ETGBD success rate is crucial. However, only a few studies have examined the procedural and anatomical factors affecting the technical success of this procedure. Additionally, it is often challenging to preoperatively assess these anatomical factors. Thus, identifying factors that the operator can control is of significant importance. Conversely, regarding the timing of surgery for AC, surgeries performed later rather than early in the course of treatment result in fewer postoperative AEs and a reduced need for conversion to open surgery owing to attenuation of inflammation and adhesions [11,12]. Similarly, in the context of ETGBD, the weakening of tissues owing to inflammation and the presence of adhesions could potentially contribute to procedural failure and AEs. Therefore, this study aimed to investigate the factors influencing technical failures, including the timing of ETGBD. Methods Study population This single-center retrospective analysis focused on patients who underwent ETGBD for AC based on clinical symptoms, laboratory data, and imaging studies in accordance with the 2018 Tokyo guidelines (TG18) between January 2016 and December 2023. The exclusion criteria were as follows: (1) patients with surgically altered gastrointestinal anatomy, except for those with Billroth -I reconstruction, and (2) individuals with pancreaticobiliary malignancies. Ethical compliance was ensured in accordance with the guidelines set by the Institutional Review Board of the hospital, and the study was conducted in accordance with the tenets of the Declaration of Helsinki. ETGBD procedure All the patients included in this study underwent ERCP under sedation. Standard duodenoscopes (JF-260V, TJF-Q260V, or TJF-Q290V; Olympus Medical Systems, Tokyo, Japan) were used to perform ETGBD. After successful cannulation of the bile duct, cholangiography was performed to identify the location of the cystic duct. Endoscopic stone extraction was performed for patients with common bile duct stones. A 0.025-inch guidewire (Visi Glide2; Olympus Medical Systems) and an ERCP catheter (PR-V614M, Olympus Medical Systems) were used to seek and advance through the cystic duct into the gallbladder. The guidewire and cannula were then advanced into the cystic duct, and a contrast medium was injected to evaluate the structure of the cystic duct, which was dilated using a 6-Fr Soehendra dilation catheter, if necessary. Subsequently, an ERCP catheter was inserted over the guidewire into the gallbladder for bile aspiration and saline irrigation. The procedure was concluded with the placement of a plastic stent (5-Fr 10-cm IYO-stent, Gadelius Medical, Tokyo, Japan) or a 6-Fr endoscopic nasobiliary drainage (ENBD) tube, as decided by the endoscopist on the basis of the specific requirements of each case. Study outcomes and definitions Data regarding the following parameters were collected: patient background, disease severity, interval from symptom onset to ETGBD, diameter of the common bile duct, presence or absence of cystic duct stones, bifurcation of the cystic duct, and cystic duct perforation. The primary outcomes were technical success rate and AEs. The severity of AC was classified according to the 2018 Tokyo Guidelines. Cystic duct perforation was identified using device dislocation, such as a guidewire or cannula, or by fluoroscopically confirming the leakage of contrast medium from the cystic duct lumen into the peritoneal cavity (Fig 1). The interval between symptom onset and ETGBD was defined as the number of days between symptom onset and ETGBD. Technical success of ETGBD was determined by the successful placement of a stent or nasobiliary drainage catheter into the gallbladder through the cystic duct. AEs were classified based on the Tokyo Criteria [13], and their severity was graded in accordance with the American Society of Gastrointestinal Endoscopy lexicon guidelines [14]. The final assessment of the direction and location of the cystic duct was determined based on findings from ERCP, computed tomography (CT), or magnetic resonance cholangiopancreatography (MRCP). Statistical analysis Continuous variables were presented as medians and interquartile ranges and compared using the Mann–Whitney U -test. Categorical variables were presented as proportions and compared using Fisher’s exact test. Multivariable logistic regression analyses were performed to identify predictive factors for the technical failure of ETGBD. The following variables were evaluated to elucidate the predictive factors: the presence of stone impaction in the cystic duct (with vs. without), common bile duct diameter (n ≤7 mm vs. >7 mm), the direction of the cystic duct (right caudal vs. right cranial + left cranial), contrast cystic duct (with vs. without), and the interval from symptom onset to ETGBD (early vs. elective). The cut-off value for common bile duct diameter was set at 7 mm, based on a previous study which reported that a common bile duct diameter of ≥7 mm contributed to the technical failure of ETGBD [15]. Receiver operating characteristic (ROC) curves for the interval from symptom onset to ETGBD for technical failure of ETGBD were plotted, and the accuracy of the area under the curve (AUC) was evaluated. The cut-off time for the interval from symptom onset to ETGBD (early and elective) was determined using the ROC curve analysis. Statistical significance was set at p < 0.05. All analyses were performed using R version 3.4.1 (The R Foundation for Statistical Computing, Vienna, Austria). Results Patient characteristics Patient characteristics are presented in Table 1 . This study included a cohort of 68 patients who underwent ETGBD between January 2016 and December 2023. The median age of the study population was 75 years, with an interquartile range of 67.5–82.5 years. Most study participants were male in 79.4%. Classification of cholecystitis severity, adhering to the TG18 identified 4.4% of the cases as mild, 77.9% as moderate, and 17.6% as severe. The median interval from symptom onset to ETGBD was seven days. The median cystic duct diameter was 3 mm, with an interquartile range of 2.6-4 mm, and stones were impacted in the cystic duct in 13.2% of cases. The median diameter of the common bile duct was 8 mm, with an interquartile range of 6–9 mm. Table 1 Patient characteristics ETGBD (n = 68) Age, median, years (IQR) 75 (67.5–82.5) Sex, male, n (%) 54 (79.4) Severity of cholecystitis, n (%) Mild 3 (4.4) Moderate 53 (77.9) Severe 12 (17.6) The interval from symptom onset to ETGBD, days (IQR) 7 (2.5–16) Presence of CBD stone, n (%) 33 (48.5) Cystic duct diameter, mm (IQR) 3 (2.6–4) Stone impaction in the cystic duct 9 (13.2) CBD diameter, median, mm (IQR) 8 (6–9) CBD, common bile duct; ETGBD, endoscopic transpapillary gallbladder drainage; IQR, interquartile range. Outcomes of ETGBD The outcomes of ETGBD are listed in Table 2 . Within the cohort of 68 patients who underwent ETGBD, the technical success rate was 64.7%. Endoscopic nasogallbladder drainage (ENGBD) defined as ENBD to gallbladder was performed in 11.8% (8cases) cases and endoscopic gallbladder stenting (EGBS) in 52.9% (36cases) cases. Removal of common bile duct stones was performed in 41.2% (28cases). Non-contrast cystic ducts were noted in 19.1% of the patients (13 cases). Most cystic ducts (94.1%, 64 patients) were oriented in the right caudal direction, with only a minority in the right or left cranial orientation, or unknown (2 cases). In cases where ETGBD was unsuccessful (n = 24), its technical failure occurred because of several factors. First, in 10 cases, severe inflammation and edema made it difficult to identify the cystic duct. Second, in eight cases, the passage of the guidewire was obstructed by tortuosity, stenosis, or stones within the cystic duct. Finally, in six cases, the passage of the stent was hindered because of the same issues of tortuosity, stenosis, or stones. Moreover, in the failure cases, alternative management strategies were employed. PTGBD, PTGBA, and ENBD were performed in 15, 2, and 5 patients, respectively. Additionally, two patients who were unfit for invasive procedures received conservative management with antibiotics. Table 2 Endoscopic procedure ETGBD n = 68 Technical success, n (%) 44 (64.7) ENGBD 8 EGBS 36 CBD stone removal, n (%) 28 (41.2) Non-contrast cystic duct, n (%) 13 (19.1) The direction of the cystic duct, n Right caudal/right cranial + left cranial/unknown 64/2/2 CBD, common bile duct; EGBS, endoscopic gallbladder stenting; ENGBD, endoscopic nasobiliary gallbladder drainage. Adverse events Table 3 summarizes the AEs associated with ETGBD. AEs were documented in 19.1% (13cases). Specific AEs included cystic duct perforation in 8.8% (6cases), pancreatitis in 5.9% (4cases), and cholangitis in 5.9% (4cases). No instances of bleeding were observed. Table 3 Adverse events ETGBD n = 68 Adverse events, n (%) 13 (19.1) Cystic duct perforation 6 (8.8) Pancreatitis 4 (5.9) Cholangitis 3 (4.4) Bleeding 0 Predictive factors for technical failure of ETGBD Using the ROC curve of the interval from symptom onset to ETGBD, the cut-off value, and AUC for successful ETGBD were calculated to be 3.0 days and 0.91 (95% CI, 0.83–0.98) (Fig. 2 ). Table 4 shows the predictive factors for the technical failure of ETGBD. Multivariate analysis revealed that early procedure (OR, 44;95% CI, 6.1–317; p < 0.01) and presence of stone impaction in the cystic duct (OR, 13.5; 95% CI, 1.41–129; p < 0.02) were independent predictive factors for technical failure of ETGBD. Table 4 Predictive factors for technical failure of ETGBD OR [95% CI] p value Early ETGBD procedure 44 [6.1–317] 8 mm) 5.92 [0.97–35.9] 0.05 The direction of the cystic duct 6.52 [0.28–152] 0.24 Right caudal Cystic duct without contrast, 1.15 [0.14–9.4] 0.9 CBD, common bile duct; ETGBD, endoscopic transpapillary gallbladder drainage Comparison of outcomes of early and delayed ETGBD Table 5 shows the subgroup analysis of ETGBD outcomes; among the 45 patients in the elective group, percutaneous drainage was more frequent before ETGBD, with 80% (36cases) having undergone PTGBD and only 2.2% (1cases) having PTGBA, compared to 4.3% (1cases) and 8.7% (2cases) in the early group, respectively (p < 0.01 for PTGBD, p = 0.26 for PTGBA). Table 5 Comparison of the outcomes of early and delayed ETGBD Early group Elective group p value n = 23 n = 45 Percutaneous drainage prior to ETGBD, n (%) PTGBD 1 (4.3) 36 (80) < 0.01 PTGBA 2 (8.7) 1 (2.2) 0.26 Technical success, n (%) 12 (52.2) 32 (71.1) 0.18 Adverse events, n (%) Cystic duct perforation 5 (21.7) 1 (2.2) 0.01 Pancreatitis 0 4 (8.8) 0.29 Cholangitis 2 (8.7) 0 0.11 ETGBD, endoscopic nasobiliary gallbladder drainage; PTGBD, percutaneous transhepatic gallbladder drainage; PTGBA, percutaneous transhepatic gallbladder aspiration Technical success was achieved in 71.1% (36cases) in the elective group and 52.2% (12cases) in the early group (p = 0.18). AEs varied significantly, with cystic duct perforation occurring in 2.2% (1cases) in the elective group compared to 21.7% (5cases) in the early group (p = 0.01). Pancreatitis was observed in 8.8% (4cases) in the elective group, while the early group did not demonstrate the occurrence of pancreatitis (p = 0.29). Conversely, cholangitis did not occur in the elective group but was observed in 8.7% (2cases) patients in the early group (p = 0.11). Discussion To the best of our knowledge, this study is the first to focus on the influence of elective ETGBD. Multivariate analysis revealed early ETGBD as a significant predictor of its technical failure. Notably, the early group had a significantly higher incidence of cystic duct perforation compared to the elective group. Several studies have investigated the factors contributing to the technical failure of ETGBD in the context of AC [ 15 – 17 ]. It has been suggested that the anatomy of cystic duct bifurcation may contribute to unsuccessful outcomes [ 16 ]. Moreover, cystic duct perforation has been reported as a factor in unsuccessful ETGBD [ 17 ]. However, preoperative identification of cystic duct bifurcation anatomy is challenging. Sato et al. [ 18 ] reported that identification of cystic duct bifurcation using CT or MRCP is possible in only 60% of cases. Similarly, cystic duct perforation is a severe AE of ETGBD and is not a pre-procedural predictive factor. This study focused on the timing of ETGBD, and early ETGBD and the presence of cystic duct stones were found to be significantly associated with the technical failure of ETGBD. elective ETGBD may not only enhance the success rates but also potentially reduce AEs. Studies suggested that patients operated on for AC after a delay of 72 h (3 days) post-onset exhibit fewer postoperative AEs and shorter hospital stays than those operated on within 72 h [ 19 ]. This could be attributed to early interventions, which lead to lower success rates and increased AEs because of inflammation-induced tissue vulnerability and adhesions. Furthermore, Sofuni and Itoi [ 20 ] reported that cystic duct perforation, a critical AE of ETGBD, was correlated with edematous inflammatory changes in the cystic duct. In our subgroup analysis, early ETGBD showed lower technical success rates and a significantly higher incidence of cystic duct perforations. elective ETGBD increases the likelihood of success and provides a safer treatment approach by minimizing AEs. However, in the elective group, 80% of the patients had previously undergone PTGBD. The use of PTGBD in suppressing inflammation and adhesion progression before surgery has frequently been reported in the literature, suggesting that PTGBD before ETGBD could be beneficial [ 21 ]. Therefore, based on the findings of this study, it is difficult to determine which approach (elective ETGBD or PTGBD) contributes more to improving technical success or reducing AEs. Nonetheless, in patients with moderate or severe acute cholecystitis, PTGBD is generally required prior to performing elective ETGBD. We therefore believe that our results offer valuable insights for clinical practice. However, prolonged hospital stays and a decline in activities of daily living may arise from PTGBD placement, underscoring the need for individualized treatment strategies based on the patient’s condition. The indications for PTGBD in patients receiving antithrombotic therapy remain controversial. While TG18 recommends avoiding PTGBD in patients on antithrombotic medication [ 2 ], the Society of Interventional Radiology advocates its use without discontinuing medication when there is a risk of thrombosis, leaving no consensus [ 22 ]. In this context, based on our clinical experience, cases necessitating emergency ETGBD may not be as frequent as expected. Therefore, in patients in whom ETGBD is expected to be challenging or those at a higher risk of post-ERCP pancreatitis, proceeding with PTGBD while on antithrombotic therapy, followed by elective ETGBD, may be a prudent strategy. In this study, the ETGBD success rate was slightly lower than the previously reported success rate. One contributing factor to this finding may be the limited selection of devices available for use. Specifically, difficulty was encountered in identifying the cystic duct because of severe inflammation and edema in 41.6% of cases, and stent passage was hindered by tortuosity, stenosis, or stones in 25% of cases. Yoshida et al. [ 23 ] reported a significantly higher success rate with SpyGlass DS-assisted ETGBD than with the conventional methods, which could help in navigating and visualizing difficult cystic ducts. Ban et al. [ 24 ] documented the successful use of a Soehendra stent retriever to fragment stone impactions within the cystic duct and facilitate successful ETGBD. The use of such devices may resolve the challenges encountered during ETGBD, and the inclusion of various devices in future studies could potentially improve the outcomes of ETGBD. The introduction of lumen-apposing metal stents (LAMS) has made EUS-GBD a notable alternative to surgery [ 25 ]. A meta-analysis has shown that EUS-GBD with LAMS achieved technical and clinical success rates of 100% and 85%, respectively [ 26 ]. Despite its effectiveness, the use of LAMS for gallbladder drainage has not been officially approved, and only a few experienced specialists perform EUS-GBD. Compared to EUS-GBD, ETGBD offers unique benefits, such as maintenance of natural anatomy and better long-term outcomes with stent placement [ 27 ]. Enhancing the technical success of ETGBD is crucial, making this research significant in advancing gallbladder drainage techniques. These treatment options should be selected according to each patient's background and conditions. Further accumulation of cases and investigation of long-term outcomes in future studies are warranted. This study had several limitations that need consideration. First, this was a single-center retrospective study and had a relatively small sample size, which may limit the generalizability of the findings, and potentially limiting its applicability to other facilities with different levels of expertise or variations in available endoscopic devices. The retrospective design could also have introduced bias affecting data collection and interpretation. Second, in this study, the direction of the cystic duct was determined using ERCP, CT, and MRCP; however, in patients with AC, accurate evaluation of the cystic duct may have been challenging because of inflammation and edema. Third, because of the small sample size in this study, it is possible that not all factors influencing technical success were adequately evaluated. Moreover, no statistically significant difference in technical success rates was observed between the early and elective ETGBD groups (52% vs. 71%; p = 0.18), a sample size calculation indicated that at least 113 patients per group would be required to reliably detect a difference of this magnitude. Further investigations through multicenter or prospective studies are warranted. Additionally, the choice to dichotomize the timing at approximately three days (derived from an ROC analysis) could introduce bias. Therefore, we conducted a sensitivity analysis using the median as the cut-off value in a multivariable model and obtained similar results. We believe this additional assessment further supports the usefulness and robustness of our findings. Fifth, our technical success rate is relatively low compared to some previous reports, which may reflect higher case complexity, limited device selection, or operator learning curves—factors we did not analyze in detail. Nonetheless, this is the first study to explore the optimal timing of ETGBD, providing valuable insights despite the aforementioned constraints. Conclusions Early ETGBD was identified as a risk factor for ETGBD failure, with a significantly higher incidence of cystic duct perforation than delayed ETGBD. Our findings suggest that an elective ETGBD approach may be safer in certain high-risk scenarios, though prospective studies are needed to confirm this strategy. Table of Abbreviations AC Acute cholecystitis AE Adverse events AUC Area under the curve CBD Common bile duct CT Computed tomography EGBS Endoscopic gallbladder stenting ENBD Endoscopic nasobiliary drainage ERCP Endoscopic retrograde cholangiopancreatography ENGBD Endoscopic nasogallbladder drainage ETGBD Endoscopic transpapillary gallbladder drainage LAMS Lumen-apposing metal stents MRCP Magnetic resonance cholangiopancreatography PTGBA Percutaneous transhepatic gallbladder aspiration PTGBD Percutaneous transhepatic gallbladder drainage ROC Receiver operating characteristic Declarations Ethics approval and consent to participate This retrospective, single-center study was approved by the Showa University Ethics Committee (Approval Number: 2024-047-A, Date: 17/05/2024), and it was conducted in accordance with the Declaration of Helsinki. The committee waived the requirement for individual patient consent for participation because all data were anonymized before analysis. Consent for publication Not applicable. This study does not include any identifiable images or personal details of the participants. Availability of data and materials Raw data were generated at Showa University Fujigaoka Hospital. Derived data supporting the findings of this study are available from the corresponding author [F.N.] on request. Competing interests The authors declare no conflict of interest associated with the contents of this article. Funding The authors did not receive any funding to conduct or publish the results of this study. Authors' contributions FN, NT, MY, and JN were responsible for the acquisition of patient data, and TA was in charge of the preparation of the manuscript and figures. YT, FN and MN participated in the acquisition and analysis of data. All authors were in agreement with the content of the manuscript. Acknowledgements None References Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, et al. 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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-6049580","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":436905850,"identity":"6faee919-3b62-42d9-bb43-c1c68eb61656","order_by":0,"name":"Fumitaka Niiya","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABCklEQVRIiWNgGAWjYBAC9gYGhgMJDAxyQLYBA2MDQoYZlxaeAxAtxqRpAYHEBnQtOAEPA+/BAw/b7NLXtjdvYPy5wyaxv4HHgOFHDQO7OU4tfAkHEtuSc7edOVbAzHsmLXHGAR4Dxp5jDMyWOKy0Z+AxAGphzt12I8eAmbHtcG7D/TcGDLwNDMwGB3DZAtZSn24GVMn4E6hlPsiWv4S1HE4wuwH0Ai9QywagFma8tjADtSScO2647UxawWHetrT6jQfYCg7LHJPA6Rce9h7jjz/KquXNjh/e+PBnm42x3AHmjQ/f1Ngk4woxcIwxskHYcJcAGRLJBri0gMEfLGJ2+LWMglEwCkbBCAIALJha84bbXoYAAAAASUVORK5CYII=","orcid":"","institution":"Showa University Fujigaoka Hospital","correspondingAuthor":true,"prefix":"","firstName":"Fumitaka","middleName":"","lastName":"Niiya","suffix":""},{"id":436905851,"identity":"6d525804-eb7c-42bb-81cc-c363f0fb677c","order_by":1,"name":"Naoki Tamai","email":"","orcid":"","institution":"Showa University Fujigaoka Hospital","correspondingAuthor":false,"prefix":"","firstName":"Naoki","middleName":"","lastName":"Tamai","suffix":""},{"id":436905853,"identity":"c5dcdd3a-6298-4501-a765-0cb0e4cbcd7f","order_by":2,"name":"Masataka Yamawaki","email":"","orcid":"","institution":"Showa University Fujigaoka Hospital","correspondingAuthor":false,"prefix":"","firstName":"Masataka","middleName":"","lastName":"Yamawaki","suffix":""},{"id":436905855,"identity":"13f40d63-ab14-47be-8877-bab779db3b22","order_by":3,"name":"Jun Noda","email":"","orcid":"","institution":"Showa University Fujigaoka Hospital","correspondingAuthor":false,"prefix":"","firstName":"Jun","middleName":"","lastName":"Noda","suffix":""},{"id":436905857,"identity":"bdc5b96b-b2f3-4da1-9f60-c0cdc989674e","order_by":4,"name":"Tetsushi Azami","email":"","orcid":"","institution":"Showa University Fujigaoka Hospital","correspondingAuthor":false,"prefix":"","firstName":"Tetsushi","middleName":"","lastName":"Azami","suffix":""},{"id":436905858,"identity":"c38aa522-aa76-429c-abcd-5038f1a876a8","order_by":5,"name":"Yuichi Takano","email":"","orcid":"","institution":"Showa University Fujigaoka Hospital","correspondingAuthor":false,"prefix":"","firstName":"Yuichi","middleName":"","lastName":"Takano","suffix":""},{"id":436905860,"identity":"ac2b7ca6-8135-47d5-a99d-9163df886eef","order_by":6,"name":"Fumiya Nishimoto","email":"","orcid":"","institution":"Showa University Fujigaoka Hospital","correspondingAuthor":false,"prefix":"","firstName":"Fumiya","middleName":"","lastName":"Nishimoto","suffix":""},{"id":436905865,"identity":"16bd5f46-6d3c-4343-b1f5-9d6a69c7ca0a","order_by":7,"name":"Masatsugu Nagahama","email":"","orcid":"","institution":"Showa University Fujigaoka Hospital","correspondingAuthor":false,"prefix":"","firstName":"Masatsugu","middleName":"","lastName":"Nagahama","suffix":""}],"badges":[],"createdAt":"2025-02-17 16:11:18","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6049580/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6049580/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12876-025-04027-2","type":"published","date":"2025-07-01T15:58:42+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":79818233,"identity":"047483ca-88f3-4d13-a3f9-dc92a7b03dbb","added_by":"auto","created_at":"2025-04-03 08:18:01","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":92608,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFluoroscopic images of cystic duct perforation.\u003c/strong\u003e Yellow head shows leakage of the contrast medium into the peritoneal cavity from the cystic duct lumen.\u003c/p\u003e","description":"","filename":"figure1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6049580/v1/51a716c0b760ba4f0d12c816.jpg"},{"id":79818232,"identity":"32a94e31-f77b-4866-bb9f-5a74ebafe767","added_by":"auto","created_at":"2025-04-03 08:18:01","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":51083,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eUsing the receiver operating characteristic (ROC) curve for the interval from symptom onset to endoscopic transpapillary gallbladder drainage (ETGBD) for technical success.\u003c/strong\u003e A cut-off value of three days (using the Youden index [sensitivity + specificity – 1]) with an area under the curve (AUC) of 0.91 (95% confidence interval [CI] 0.83-0.98) was determined.\u003c/p\u003e","description":"","filename":"figure2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-6049580/v1/91d82a426d7f8eca10b962de.jpg"},{"id":86179308,"identity":"4ea8791a-32ba-4d78-ac58-cafa6ebf8305","added_by":"auto","created_at":"2025-07-07 16:17:31","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":927314,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6049580/v1/acda3a83-7b98-4183-b46c-8a321d651672.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Inflauence of elective endoscopic transpapillary gallbladder drainage on the management of acute cholecystitis: A retrospective study","fulltext":[{"header":"Background","content":"\u003cp\u003eLaparoscopic cholecystectomy is an established standard treatment for acute cholecystitis (AC) [1-3]. However, in some patients, surgical intervention may be contraindicated owing to the presence of comorbid conditions. In such patients, nonsurgical options for gallbladder drainage, such as percutaneous transhepatic gallbladder drainage (PTGBD), percutaneous transhepatic gallbladder aspiration (PTGBA), endoscopic transpapillary gallbladder drainage (ETGBD), and endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), can be used to decompress the gallbladder effectively. The revised 2018 Tokyo Guidelines recommend PTGBD as the primary nonsurgical alternative for the management of AC [2]. However, significant recurrence rates of cholecystitis (22\u0026ndash;47%) have been reported in patients who do not undergo cholecystectomy after the removal of the percutaneous catheter [4,5]. Therefore, the use of ETGBD as an internal stent is an important treatment approach.\u003c/p\u003e\n\u003cp\u003eETGBD is a method used for gallbladder drainage in the treatment of AC [6-9]. However, ETGBD is considerably challenging to perform, with reported success rates ranging between 64% and 100% [10]. Moreover, there is a risk of adverse events (AEs) related to endoscopic retrograde cholangiopancreatography (ERCP), as well as the likelihood of perforation of the cystic duct during the ETGBD procedure. Therefore, determining how to increase the ETGBD success rate is crucial. However, only a few studies have examined the procedural and anatomical factors affecting the technical success of this procedure. Additionally, it is often challenging to preoperatively assess these anatomical factors. Thus, identifying factors that the operator can control is of significant importance.\u003c/p\u003e\n\u003cp\u003eConversely, regarding the timing of surgery for AC, surgeries performed later rather than early in the course of treatment result in fewer postoperative AEs and a reduced need for conversion to open surgery owing to attenuation of inflammation and adhesions [11,12]. Similarly, in the context of ETGBD, the weakening of tissues owing to inflammation and the presence of adhesions could potentially contribute to procedural failure and AEs. Therefore, this study aimed to investigate the factors influencing technical failures, including the timing of ETGBD.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStudy population\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis single-center retrospective analysis focused on patients who underwent ETGBD for AC based on clinical symptoms, laboratory data, and imaging studies in accordance with the 2018 Tokyo guidelines (TG18) between January 2016 and December 2023. The exclusion criteria were as follows: (1) patients with surgically altered gastrointestinal anatomy, except for those with Billroth -I reconstruction, and (2) individuals with pancreaticobiliary malignancies. Ethical compliance was ensured in accordance with the guidelines set by the Institutional Review Board of the hospital, and the study was conducted in accordance with the tenets of the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eETGBD procedure\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll the patients included in this study underwent ERCP under sedation.\u0026nbsp;Standard duodenoscopes (JF-260V, TJF-Q260V, or TJF-Q290V; Olympus Medical Systems, Tokyo, Japan) were used to perform ETGBD. After successful cannulation of the bile duct, cholangiography was performed to identify the location of the cystic duct. Endoscopic stone extraction was performed for patients with common bile duct stones. A 0.025-inch guidewire (Visi Glide2; Olympus Medical Systems) and an ERCP catheter (PR-V614M, Olympus Medical Systems) were used to seek and advance through the cystic duct into the gallbladder. The guidewire and cannula were then advanced into the cystic duct, and a contrast medium was injected to evaluate the structure of the cystic duct, which was dilated using a 6-Fr Soehendra dilation catheter, if necessary. Subsequently, an ERCP catheter was inserted over the guidewire into the gallbladder for bile aspiration and saline irrigation. The procedure was concluded with the placement of a plastic stent (5-Fr 10-cm IYO-stent, Gadelius Medical, Tokyo, Japan) or a 6-Fr endoscopic nasobiliary drainage (ENBD) tube, as decided by the endoscopist on the basis of the specific requirements of each case.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStudy outcomes and definitions\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData regarding the following parameters were collected: patient background, disease severity, interval from symptom onset to ETGBD, diameter of the common bile duct, presence or absence of cystic duct stones, bifurcation of the cystic duct, and cystic duct perforation. The primary outcomes were technical success rate and AEs.\u003c/p\u003e\n\u003cp\u003eThe severity of AC was classified according to the 2018 Tokyo Guidelines. Cystic duct perforation was identified using device dislocation, such as a guidewire or cannula, or by fluoroscopically confirming the leakage of contrast medium from the cystic duct lumen into the peritoneal cavity (Fig 1). The interval between symptom onset and ETGBD was defined as the number of days between symptom onset and ETGBD. Technical success of ETGBD was determined by the successful placement of a stent or nasobiliary drainage catheter into the gallbladder through the cystic duct. AEs were classified based on the Tokyo Criteria [13], and their severity was graded in accordance with the American Society of Gastrointestinal Endoscopy lexicon guidelines [14].\u003c/p\u003e\n\u003cp\u003eThe final assessment of the direction and location of the cystic duct was determined based on findings from ERCP, computed tomography (CT), or magnetic resonance cholangiopancreatography (MRCP).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eStatistical analysis\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eContinuous variables were presented as medians and interquartile ranges and compared using the Mann–Whitney \u003cem\u003eU\u003c/em\u003e-test. Categorical variables were presented as proportions and compared using Fisher’s exact test. Multivariable logistic regression analyses were performed to identify predictive factors for the technical failure of ETGBD. The following variables were evaluated to elucidate the predictive factors: the presence of stone impaction in the cystic duct (with vs. without), common bile duct diameter (n ≤7 mm vs. \u0026gt;7 mm), the direction of the cystic duct (right caudal vs. right cranial + left cranial), contrast cystic duct (with vs. without), and the interval from symptom onset to ETGBD (early vs. elective). The cut-off value for common bile duct diameter was set at 7 mm, based on a previous study which reported that a common bile duct diameter of ≥7 mm contributed to the technical failure of ETGBD [15]. Receiver operating characteristic (ROC) curves for the interval from symptom onset to ETGBD for technical failure of ETGBD were plotted, and the accuracy of the area under the curve (AUC) was evaluated. The cut-off time for the interval from symptom onset to ETGBD (early and elective) was determined using the ROC curve analysis. Statistical significance was set at p \u0026lt; 0.05. All analyses were performed using R version 3.4.1 (The R Foundation for Statistical Computing, Vienna, Austria).\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003ePatient characteristics\u003c/h2\u003e \u003cp\u003ePatient characteristics are presented in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. This study included a cohort of 68 patients who underwent ETGBD between January 2016 and December 2023. The median age of the study population was 75 years, with an interquartile range of 67.5\u0026ndash;82.5 years. Most study participants were male in 79.4%. Classification of cholecystitis severity, adhering to the TG18 identified 4.4% of the cases as mild, 77.9% as moderate, and 17.6% as severe. The median interval from symptom onset to ETGBD was seven days. The median cystic duct diameter was 3 mm, with an interquartile range of 2.6-4 mm, and stones were impacted in the cystic duct in 13.2% of cases. The median diameter of the common bile duct was 8 mm, with an interquartile range of 6\u0026ndash;9 mm.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePatient characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eETGBD (n\u0026thinsp;=\u0026thinsp;68)\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge, median, years (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e75 (67.5\u0026ndash;82.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex, male, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e54 (79.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSeverity of cholecystitis, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMild\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (4.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eModerate\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e53 (77.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSevere\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (17.6)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe interval from symptom onset to ETGBD, days (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7 (2.5\u0026ndash;16)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePresence of CBD stone, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e33 (48.5)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCystic duct diameter, mm (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (2.6\u0026ndash;4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStone impaction in the cystic duct\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (13.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCBD diameter, median, mm (IQR)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8 (6\u0026ndash;9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003eCBD, common bile duct; ETGBD, endoscopic transpapillary gallbladder drainage; IQR, interquartile range.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eOutcomes of ETGBD\u003c/h2\u003e \u003cp\u003eThe outcomes of ETGBD are listed in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Within the cohort of 68 patients who underwent ETGBD, the technical success rate was 64.7%. Endoscopic nasogallbladder drainage (ENGBD) defined as ENBD to gallbladder was performed in 11.8% (8cases) cases and endoscopic gallbladder stenting (EGBS) in 52.9% (36cases) cases. Removal of common bile duct stones was performed in 41.2% (28cases). Non-contrast cystic ducts were noted in 19.1% of the patients (13 cases). Most cystic ducts (94.1%, 64 patients) were oriented in the right caudal direction, with only a minority in the right or left cranial orientation, or unknown (2 cases). In cases where ETGBD was unsuccessful (n\u0026thinsp;=\u0026thinsp;24), its technical failure occurred because of several factors. First, in 10 cases, severe inflammation and edema made it difficult to identify the cystic duct. Second, in eight cases, the passage of the guidewire was obstructed by tortuosity, stenosis, or stones within the cystic duct. Finally, in six cases, the passage of the stent was hindered because of the same issues of tortuosity, stenosis, or stones. Moreover, in the failure cases, alternative management strategies were employed. PTGBD, PTGBA, and ENBD were performed in 15, 2, and 5 patients, respectively. Additionally, two patients who were unfit for invasive procedures received conservative management with antibiotics.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eEndoscopic procedure\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eETGBD\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;68\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTechnical success, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e44 (64.7)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eENGBD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEGBS\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e36\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCBD stone removal, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e28 (41.2)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNon-contrast cystic duct, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (19.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe direction of the cystic duct, n\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRight caudal/right cranial\u0026thinsp;+\u0026thinsp;left cranial/unknown\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e64/2/2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003eCBD, common bile duct; EGBS, endoscopic gallbladder stenting; ENGBD, endoscopic nasobiliary gallbladder drainage.\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eAdverse events\u003c/h3\u003e\n\u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e summarizes the AEs associated with ETGBD. AEs were documented in 19.1% (13cases). Specific AEs included cystic duct perforation in 8.8% (6cases), pancreatitis in 5.9% (4cases), and cholangitis in 5.9% (4cases). No instances of bleeding were observed.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eAdverse events\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eETGBD n\u0026thinsp;=\u0026thinsp;68\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdverse events, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e13 (19.1)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCystic duct perforation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6 (8.8)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePancreatitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (5.9)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCholangitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (4.4)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBleeding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\n\u003ch3\u003ePredictive factors for technical failure of ETGBD\u003c/h3\u003e\n\u003cp\u003eUsing the ROC curve of the interval from symptom onset to ETGBD, the cut-off value, and AUC for successful ETGBD were calculated to be 3.0 days and 0.91 (95% CI, 0.83\u0026ndash;0.98) (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e shows the predictive factors for the technical failure of ETGBD. Multivariate analysis revealed that early procedure (OR, 44;95% CI, 6.1\u0026ndash;317; p\u0026thinsp;\u0026lt;\u0026thinsp;0.01) and presence of stone impaction in the cystic duct (OR, 13.5; 95% CI, 1.41\u0026ndash;129; p\u0026thinsp;\u0026lt;\u0026thinsp;0.02) were independent predictive factors for technical failure of ETGBD.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePredictive factors for technical failure of ETGBD\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eOR [95% CI]\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003ep value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eEarly ETGBD procedure\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e44 [6.1\u0026ndash;317]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eThe presence of stone impaction in the cystic duct\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e13.5 [1.41\u0026ndash;129]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003e0.02\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eCBD diameter (\u0026gt;\u0026thinsp;8 mm)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e5.92 [0.97\u0026ndash;35.9]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003e0.05\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eThe direction of the cystic duct\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e6.52 [0.28\u0026ndash;152]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003e0.24\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c4\" namest=\"c2\"\u003e \u003cp\u003eRight caudal\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colspan=\"3\" nameend=\"c3\" namest=\"c1\"\u003e \u003cp\u003eCystic duct without contrast,\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003e1.15 [0.14\u0026ndash;9.4]\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c7\" namest=\"c6\"\u003e \u003cp\u003e0.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"7\"\u003eCBD, common bile duct; ETGBD, endoscopic transpapillary gallbladder drainage\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e\n\u003ch3\u003eComparison of outcomes of early and delayed ETGBD\u003c/h3\u003e\n\u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab5\" class=\"InternalRef\"\u003e5\u003c/span\u003e shows the subgroup analysis of ETGBD outcomes; among the 45 patients in the elective group, percutaneous drainage was more frequent before ETGBD, with 80% (36cases) having undergone PTGBD and only 2.2% (1cases) having PTGBA, compared to 4.3% (1cases) and 8.7% (2cases) in the early group, respectively (p\u0026thinsp;\u0026lt;\u0026thinsp;0.01 for PTGBD, p\u0026thinsp;=\u0026thinsp;0.26 for PTGBA).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab5\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 5\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eComparison of the outcomes of early and delayed ETGBD\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEarly group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eElective group\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003ep value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;23\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;45\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePercutaneous drainage prior to ETGBD, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePTGBD\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1 (4.3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36 (80)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePTGBA\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (8.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (2.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.26\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTechnical success, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12 (52.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e32 (71.1)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.18\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAdverse events, n (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCystic duct perforation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5 (21.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (2.2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePancreatitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (8.8)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.29\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCholangitis\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2 (8.7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0.11\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"4\"\u003eETGBD, endoscopic nasobiliary gallbladder drainage; PTGBD, percutaneous transhepatic gallbladder drainage; PTGBA, percutaneous transhepatic gallbladder aspiration\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eTechnical success was achieved in 71.1% (36cases) in the elective group and 52.2% (12cases) in the early group (p\u0026thinsp;=\u0026thinsp;0.18). AEs varied significantly, with cystic duct perforation occurring in 2.2% (1cases) in the elective group compared to 21.7% (5cases) in the early group (p\u0026thinsp;=\u0026thinsp;0.01). Pancreatitis was observed in 8.8% (4cases) in the elective group, while the early group did not demonstrate the occurrence of pancreatitis (p\u0026thinsp;=\u0026thinsp;0.29). Conversely, cholangitis did not occur in the elective group but was observed in 8.7% (2cases) patients in the early group (p\u0026thinsp;=\u0026thinsp;0.11).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eTo the best of our knowledge, this study is the first to focus on the influence of elective ETGBD. Multivariate analysis revealed early ETGBD as a significant predictor of its technical failure. Notably, the early group had a significantly higher incidence of cystic duct perforation compared to the elective group.\u003c/p\u003e \u003cp\u003eSeveral studies have investigated the factors contributing to the technical failure of ETGBD in the context of AC [\u003cspan additionalcitationids=\"CR16\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. It has been suggested that the anatomy of cystic duct bifurcation may contribute to unsuccessful outcomes [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Moreover, cystic duct perforation has been reported as a factor in unsuccessful ETGBD [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. However, preoperative identification of cystic duct bifurcation anatomy is challenging. Sato et al. [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] reported that identification of cystic duct bifurcation using CT or MRCP is possible in only 60% of cases. Similarly, cystic duct perforation is a severe AE of ETGBD and is not a pre-procedural predictive factor. This study focused on the timing of ETGBD, and early ETGBD and the presence of cystic duct stones were found to be significantly associated with the technical failure of ETGBD.\u003c/p\u003e \u003cp\u003eelective ETGBD may not only enhance the success rates but also potentially reduce AEs. Studies suggested that patients operated on for AC after a delay of 72 h (3 days) post-onset exhibit fewer postoperative AEs and shorter hospital stays than those operated on within 72 h [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. This could be attributed to early interventions, which lead to lower success rates and increased AEs because of inflammation-induced tissue vulnerability and adhesions. Furthermore, Sofuni and Itoi [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] reported that cystic duct perforation, a critical AE of ETGBD, was correlated with edematous inflammatory changes in the cystic duct. In our subgroup analysis, early ETGBD showed lower technical success rates and a significantly higher incidence of cystic duct perforations. elective ETGBD increases the likelihood of success and provides a safer treatment approach by minimizing AEs. However, in the elective group, 80% of the patients had previously undergone PTGBD. The use of PTGBD in suppressing inflammation and adhesion progression before surgery has frequently been reported in the literature, suggesting that PTGBD before ETGBD could be beneficial [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Therefore, based on the findings of this study, it is difficult to determine which approach (elective ETGBD or PTGBD) contributes more to improving technical success or reducing AEs. Nonetheless, in patients with moderate or severe acute cholecystitis, PTGBD is generally required prior to performing elective ETGBD. We therefore believe that our results offer valuable insights for clinical practice. However, prolonged hospital stays and a decline in activities of daily living may arise from PTGBD placement, underscoring the need for individualized treatment strategies based on the patient\u0026rsquo;s condition.\u003c/p\u003e \u003cp\u003eThe indications for PTGBD in patients receiving antithrombotic therapy remain controversial. While TG18 recommends avoiding PTGBD in patients on antithrombotic medication [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e], the Society of Interventional Radiology advocates its use without discontinuing medication when there is a risk of thrombosis, leaving no consensus [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. In this context, based on our clinical experience, cases necessitating emergency ETGBD may not be as frequent as expected. Therefore, in patients in whom ETGBD is expected to be challenging or those at a higher risk of post-ERCP pancreatitis, proceeding with PTGBD while on antithrombotic therapy, followed by elective ETGBD, may be a prudent strategy.\u003c/p\u003e \u003cp\u003eIn this study, the ETGBD success rate was slightly lower than the previously reported success rate. One contributing factor to this finding may be the limited selection of devices available for use. Specifically, difficulty was encountered in identifying the cystic duct because of severe inflammation and edema in 41.6% of cases, and stent passage was hindered by tortuosity, stenosis, or stones in 25% of cases. Yoshida et al. [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e] reported a significantly higher success rate with SpyGlass DS-assisted ETGBD than with the conventional methods, which could help in navigating and visualizing difficult cystic ducts. Ban et al. [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e] documented the successful use of a Soehendra stent retriever to fragment stone impactions within the cystic duct and facilitate successful ETGBD. The use of such devices may resolve the challenges encountered during ETGBD, and the inclusion of various devices in future studies could potentially improve the outcomes of ETGBD.\u003c/p\u003e \u003cp\u003eThe introduction of lumen-apposing metal stents (LAMS) has made EUS-GBD a notable alternative to surgery [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. A meta-analysis has shown that EUS-GBD with LAMS achieved technical and clinical success rates of 100% and 85%, respectively [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Despite its effectiveness, the use of LAMS for gallbladder drainage has not been officially approved, and only a few experienced specialists perform EUS-GBD. Compared to EUS-GBD, ETGBD offers unique benefits, such as maintenance of natural anatomy and better long-term outcomes with stent placement [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Enhancing the technical success of ETGBD is crucial, making this research significant in advancing gallbladder drainage techniques. These treatment options should be selected according to each patient's background and conditions. Further accumulation of cases and investigation of long-term outcomes in future studies are warranted.\u003c/p\u003e \u003cp\u003eThis study had several limitations that need consideration. First, this was a single-center retrospective study and had a relatively small sample size, which may limit the generalizability of the findings, and potentially limiting its applicability to other facilities with different levels of expertise or variations in available endoscopic devices. The retrospective design could also have introduced bias affecting data collection and interpretation. Second, in this study, the direction of the cystic duct was determined using ERCP, CT, and MRCP; however, in patients with AC, accurate evaluation of the cystic duct may have been challenging because of inflammation and edema. Third, because of the small sample size in this study, it is possible that not all factors influencing technical success were adequately evaluated. Moreover, no statistically significant difference in technical success rates was observed between the early and elective ETGBD groups (52% vs. 71%; p\u0026thinsp;=\u0026thinsp;0.18), a sample size calculation indicated that at least 113 patients per group would be required to reliably detect a difference of this magnitude. Further investigations through multicenter or prospective studies are warranted. Additionally, the choice to dichotomize the timing at approximately three days (derived from an ROC analysis) could introduce bias. Therefore, we conducted a sensitivity analysis using the median as the cut-off value in a multivariable model and obtained similar results. We believe this additional assessment further supports the usefulness and robustness of our findings. Fifth, our technical success rate is relatively low compared to some previous reports, which may reflect higher case complexity, limited device selection, or operator learning curves\u0026mdash;factors we did not analyze in detail. Nonetheless, this is the first study to explore the optimal timing of ETGBD, providing valuable insights despite the aforementioned constraints.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eEarly ETGBD was identified as a risk factor for ETGBD failure, with a significantly higher incidence of cystic duct perforation than delayed ETGBD. Our findings suggest that an elective ETGBD approach may be safer in certain high-risk scenarios, though prospective studies are needed to confirm this strategy.\u003c/p\u003e "},{"header":"Table of Abbreviations","content":" \u003cp\u003eAC Acute cholecystitis\u003c/p\u003e \u003cp\u003eAE Adverse events\u003c/p\u003e \u003cp\u003eAUC Area under the curve\u003c/p\u003e \u003cp\u003eCBD Common bile duct\u003c/p\u003e \u003cp\u003eCT Computed tomography\u003c/p\u003e \u003cp\u003eEGBS Endoscopic gallbladder stenting\u003c/p\u003e \u003cp\u003eENBD Endoscopic nasobiliary drainage\u003c/p\u003e \u003cp\u003eERCP Endoscopic retrograde cholangiopancreatography\u003c/p\u003e \u003cp\u003eENGBD Endoscopic nasogallbladder drainage\u003c/p\u003e \u003cp\u003eETGBD Endoscopic transpapillary gallbladder drainage\u003c/p\u003e \u003cp\u003eLAMS Lumen-apposing metal stents\u003c/p\u003e \u003cp\u003eMRCP Magnetic resonance cholangiopancreatography\u003c/p\u003e \u003cp\u003ePTGBA Percutaneous transhepatic gallbladder aspiration\u003c/p\u003e \u003cp\u003ePTGBD Percutaneous transhepatic gallbladder drainage\u003c/p\u003e \u003cp\u003eROC Receiver operating characteristic\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis retrospective, single-center study was approved by the Showa University Ethics Committee (Approval Number: 2024-047-A, Date: 17/05/2024), and it was conducted in accordance with the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003eThe committee waived the requirement for individual patient consent for participation because all data were anonymized before analysis.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable. This study does not include any identifiable images or personal details of the participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRaw data were generated at Showa University Fujigaoka Hospital. Derived data supporting the findings of this study are available from the corresponding author [F.N.] on request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflict of interest associated with the contents of this article.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors did not receive any funding to conduct or publish the results of this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors' contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFN, NT, MY, and JN were responsible for the acquisition of patient data, and TA was in\u0026nbsp;\u003c/p\u003e\n\u003cp\u003echarge of the preparation of the manuscript and figures. YT, FN and MN participated in\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ethe acquisition and analysis of data. All authors were in agreement with the content of\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ethe manuscript.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eYokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, et al. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobil Pancreat Sci. 2018;25:41-54.\u003c/li\u003e\n\u003cli\u003eMori Y, Itoi T, Baron TH, Takada T, Strasberg SM, Pitt HA, et al. Tokyo Guidelines 2018: management strategies for gallbladder drainage in patients with acute cholecystitis (with videos). J Hepatobil Pancreat Sci. 2018;25:87-95.\u003c/li\u003e\n\u003cli\u003eOkamoto K, Suzuki K, Takada T, Strasberg SM, Asbun HJ, Endo I, et al. Tokyo Guidelines 2018: flowchart for the management of acute cholecystitis. J Hepatobil Pancreat Sci. 2018;25:55-72.\u003c/li\u003e\n\u003cli\u003eSanjay P, Mittapalli D, Marioud A, White RD, Ram R, Alijani A. Clinical outcomes of a percutaneous cholecystostomy for acute cholecystitis: a multicentre analysis. HPB (Oxford). 2013;15:511-6.\u003c/li\u003e\n\u003cli\u003eMcGillicuddy EA, Schuster KM, Barre K, Suarez L, Hall MR, Kaml GJ, et al. Non-operative management of acute cholecystitis in the elderly. Br J Surg. 2012;99:1254-61.\u003c/li\u003e\n\u003cli\u003eItoi T, Sofuni A, Itokawa F, Tsuchiya T, Kurihara T, Ishii K, et al. Endoscopic transpapillary gallbladder drainage in patients with acute cholecystitis in whom percutaneous transhepatic approach is contraindicated or anatomically impossible (with video). Gastrointest Endosc. 2008;68:455-60.\u003c/li\u003e\n\u003cli\u003eKjaer DW, Kruse A, Funch-Jensen P. Endoscopic gallbladder drainage of patients with acute cholecystitis. Endoscopy. 2007;39:304-8.\u003c/li\u003e\n\u003cli\u003eSchlenker C, Trotter JF, Shah RJ, Everson G, Chen YK, Antillon D, et al. Endoscopic gallbladder stent placement for treatment of symptomatic cholelithiasis in patients with end-stage liver disease. Am J Gastroenterol. 2006;101:278-83.\u003c/li\u003e\n\u003cli\u003eInoue T, Okumura F, Kachi K, Fukusada S, Iwasaki H, Ozeki T, et al. Long-term outcomes of endoscopic gallbladder stenting in high-risk surgical patients with calculous cholecystitis (with videos). Gastrointest Endosc. 2016;83:905-13.\u003c/li\u003e\n\u003cli\u003eItoi T, Coelho-Prabhu N, Baron TH. Endoscopic gallbladder drainage for management of acute cholecystitis. Gastrointest Endosc. 2010;71:1038-45.\u003c/li\u003e\n\u003cli\u003eKarakayali FY, Akdur A, Kirnap M, Harman A, Ekici Y, Moray G. Emergency cholecystectomy vs percutaneous cholecystostomy plus delayed cholecystectomy for patients with acute cholecystitis. Hepatobiliary Pancreat Dis Int. 2014;13:316-22.\u003c/li\u003e\n\u003cli\u003eEl-Gendi A, El-Shafei M, Emara D. Emergency versus delayed cholecystectomy after percutaneous transhepatic gallbladder drainage in grade II acute cholecystitis patients. J Gastrointest Surg. 2017;21:284-93.\u003c/li\u003e\n\u003cli\u003eIsayama H, Hamada T, Yasuda I, Itoi T, Ryozawa S, Nakai Y, et al. Tokyo criteria 2014 for transpapillary biliary stenting. Dig Endosc. 2015;27:259-64.\u003c/li\u003e\n\u003cli\u003eCotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, \u003cem\u003eet al\u003c/em\u003e. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010;71:446-54.\u003c/li\u003e\n\u003cli\u003eMaruta A, Iwata K, Iwashita T, Yoshida K, Ando N, Toda K, et al. Factors affecting technical success of endoscopic transpapillary gallbladder drainage for acute cholecystitis. J Hepatobil Pancreat Sci. 2020;27:429-36.\u003c/li\u003e\n\u003cli\u003eHirakawa N, Yamamoto K, Sofuni A, Tsuchiya T, Ishii K, Tanaka R, et al. Factors predicting technical failure of endoscopic transpapillary gallbladder drainage for acute cholecystitis. DEN Open. 2024;4:e308.\u003c/li\u003e\n\u003cli\u003eSato J, Nakahara K, Michikawa Y, Morita R, Suetani K, Sekine A, et al. Clinical outcomes and predictors of technical failure of endoscopic transpapillary gallbladder drainage in acute cholecystitis. Scand J Gastroenterol. 2023;58:286-90.\u003c/li\u003e\n\u003cli\u003eSato J, Nakahara K, Michikawa Y, Morita R, Suetani K, Sekine A, et al. The influence of pre-procedural imaging and cystic duct cholangiography on endoscopic transpapillary gallbladder drainage in acute cholecystitis. Diagnostics (Basel). 2021;11:1286.\u003c/li\u003e\n\u003cli\u003eHan IW, Jang JY, Kang MJ, Lee KB, Lee SE, Kim SW. Early versus delayed laparoscopic cholecystectomy after percutaneous transhepatic gallbladder drainage. J Hepatobil Pancreat Sci. 2012;19:187-93.\u003c/li\u003e\n\u003cli\u003eSofuni A, Itoi T. Transpapillary gallbladder drainage: when and how? Endosc Int Open. 2019;7:E1115-6.\u003c/li\u003e\n\u003cli\u003eKim KH, Sung CK, Park BK, Kim WK, Oh CW, Kim KS. Percutaneous gallbladder drainage for delayed laparoscopic cholecystectomy in patients with acute cholecystitis. Am J Surg. 2000;179:111-3.\u003c/li\u003e\n\u003cli\u003ePatel IJ, Davidson JC, Nikolic B, Salazar GM, Schwartzberg MS, Walker TG, et al. Consensus guidelines for periprocedural management of coagulation status and hemostasis risk in percutaneous image-guided interventions. J Vasc Interv Radiol. 2012;23:727-36.\u003c/li\u003e\n\u003cli\u003eYoshida M, Naitoh I, Hayashi K, Jinno N, Hori Y, Natsume M, et al. Four-step classification of endoscopic transpapillary gallbladder drainage and the practical efficacy of cholangioscopic assistance. Gut Liver. 2021;15:476-85.\u003c/li\u003e\n\u003cli\u003eBan T, Kubota Y, Takahama T, Ando T, Joh T. Soehendra stent retriever as a useful delivery device of drainage stent for passing an impacted cystic duct stone in a patient with acute cholecystitis. DEN Open. 2022;2:e78.\u003c/li\u003e\n\u003cli\u003eSaumoy M, Yang J, Bhatt A, Bucobo JC, Chandrasekhara V, Copland AP, et al. Endoscopic therapies for gallbladder drainage. Gastrointest Endosc. 2021;94:671-84.\u003c/li\u003e\n\u003cli\u003eKamal F, Khan MA, Lee-Smith W, Sharma S, Acharya A, Farooq U, et al. Efficacy and safety of EUS- guided gallbladder drainage for rescue treatment of malignant biliary obstruction: a systematic review and meta-analysis. Endosc Ultrasound 2023;12:8-15. \u003c/li\u003e\n\u003cli\u003ePark SW, Lee SS. Current status of endoscopic management of cholecystitis. Dig Endosc. 2022;34:439-50.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-gastroenterology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmge","sideBox":"Learn more about [BMC Gastroenterology](http://bmcgastroenterol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmge/default.aspx","title":"BMC Gastroenterology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Acute cholecystitis, Endoscopic transpapillary gallbladder drainage, Laparoscopic cholecystectomy, Postoperative adverse events","lastPublishedDoi":"10.21203/rs.3.rs-6049580/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6049580/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eEndoscopic transpapillary gallbladder drainage (ETGBD) is used for managing acute cholecystitis (AC) in patients contraindicated for surgery; however, ETGBD is considered challenging, has comparatively lower success rates, and is associated with severe adverse events (AEs). Only a few studies have examined the procedural and anatomical factors affecting technical ETGBD success. This study identified predictive factors for ETGBD in AC to improve success rates and minimize AEs.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis study assessed patients treated with ETGBD for AC. Factors associated with technical failure were analyzed based on interval from symptom onset to ETGBD, presence of cystic duct stones, and cystic duct diameter.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eAmong 68 patients, the technical success and AE rates were 64.7% and 19.1%, respectively (cystic duct perforation, 8.8%; pancreatitis, 5.9%). Multivariate analysis revealed that early ETGBD and stone impaction in the cystic duct were significant factors associated with technical ETGBD failure. Subgroup analysis demonstrated that early ETGBD was associated with a significantly higher risk of cystic duct perforation and a lower success rate than delayed intervention. Thus, elective ETGBD may enhance procedural success, reducing the risk of cystic duct perforation.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eElective ETGBD may be considered in cases where ETGBD is anticipated to be challenging.\u003c/p\u003e","manuscriptTitle":"Inflauence of elective endoscopic transpapillary gallbladder drainage on the management of acute cholecystitis: A retrospective study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-03 08:17:57","doi":"10.21203/rs.3.rs-6049580/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-04-03T17:51:18+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-02T09:38:00+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-01T12:58:01+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"144805868947995954334388149966993395373","date":"2025-04-01T12:32:41+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"248558991493283621721691706583376491370","date":"2025-04-01T09:30:56+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-04-01T09:22:05+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-04-01T08:54:34+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Gastroenterology","date":"2025-03-31T16:09:38+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-gastroenterology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmge","sideBox":"Learn more about [BMC Gastroenterology](http://bmcgastroenterol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmge/default.aspx","title":"BMC Gastroenterology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"c75e3d75-e643-48c3-85f5-ae5a0e3c3435","owner":[],"postedDate":"April 3rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-07-07T16:08:12+00:00","versionOfRecord":{"articleIdentity":"rs-6049580","link":"https://doi.org/10.1186/s12876-025-04027-2","journal":{"identity":"bmc-gastroenterology","isVorOnly":false,"title":"BMC Gastroenterology"},"publishedOn":"2025-07-01 15:58:42","publishedOnDateReadable":"July 1st, 2025"},"versionCreatedAt":"2025-04-03 08:17:57","video":"","vorDoi":"10.1186/s12876-025-04027-2","vorDoiUrl":"https://doi.org/10.1186/s12876-025-04027-2","workflowStages":[]},"version":"v1","identity":"rs-6049580","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6049580","identity":"rs-6049580","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}