Endoscopic Choledochoduodenostomy versus Gallbladder Drainage for Malignant Biliary Obstruction: A Propensity Score Matched Study

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Methods : We conducted a multicenter, retrospective study of patients undergoing EUS-GB or EUS-CBD for MDBO between January 2015 and October 2024. Primary outcomes were technical and clinical success. Secondary outcomes included procedural time, 6-month reintervention, adverse events (AEs), and all-cause mortality. Propensity score matching (PSM) was used to adjust for baseline differences. Results: Eighty-two patients were included (22 EUS-GB, 60 EUS-CBD). Technical success was comparable between groups (95.5% vs. 96.7%). EUS-GB was used as salvage in 50% of cases when EUS-CBD was not feasible, with a 90.9% technical success rate. PSM yielded 21 matched pairs. Clinical success was similar (95.2% EUS-GB vs. 85.7% EUS-CBD, p =0.61). EUS-CBD had significantly lower 6-month reintervention (4.8% vs. 23.8%, p =0.004) and stent-related complications (0% vs. 18.9%). Adverse event rates and all-cause mortality were similar. Median follow-up was 116 days (IQR: 51–300). In the EUS-GB group, pre-procedural cystic duct patency predicted clinical success (94.1%). Conclusion: EUS-GB is a technically effective and clinically comparable alternative to EUS-CDS for MDBO, with significantly fewer reinterventions and stent-related complications. When cystic duct patency is confirmed on imaging, EUS-GB may be considered as a primary approach or salvage strategy for biliary drainage in MDBO. direct access biliary drainage choledochoduodenostomy endoscopic ultrasound guided gallbladder drainage malignant biliary obstruction endoscopic ultrasound Figures Figure 1 Figure 2 Introduction Biliary drainage is recommended for patients with biliary tract obstruction, which may be caused by malignant distal biliary obstruction (MDBO), regardless of the presence of infection. According to a joint statement released by multiple gastrointestinal societies, including the American College of Gastroenterology (ACG), the American Society of Gastrointestinal Endoscopy (ASGE), and the European Society of Gastrointestinal Endoscopy (ESGE), endoscopic retrograde cholangiopancreatography (ERCP) remains the primary interventional approach for obstructive jaundice. With a failure rate of up to 10–20% for MDBO, interventional radiology techniques or endoscopic ultrasound (EUS)-guided biliary drainage are considered alternative options in cases of failed ERCP. Such failures may be attributed to factors including duodenal stenosis, tumor encroachment around the papilla, or challenges in biliary cannulation (1-3). Previous multicenter RCT demonstrated EUS-guided choledochoduodenostomy (EUS-CBD) was associated with higher technical success and shorter procedural time than ERCP in unresectable MDBO patients.(4) Due to its high technical feasibility and efficacy, EUS-CBD with lumen-apposing metal stents (LAMS) for biliary drainage has emerged as an alternative approach for patients in whom ERCP has failed. With the emergence of endoscopic ultrasound-guided gallbladder drainage (EUS-GB), this technique has been introduced as an alternative to percutaneous gallbladder drainage (PT-GB) for biliary drainage in patients with acute cholecystitis who have significant comorbidities and are considered unfit for surgery. However, long-term PT-GB is associated with tube dysfunction, pain, bile leak, readmission, and the necessity for reintervention.(5, 6) EUS-GB has less overall adverse events, shorter hospital stays and unplanned reinterventions, and readmissions compared with PT-GB in acute cholecystitis.(7, 8) While EUS-CBD demonstrates a high technical success rate and a favorable risk profile in MDBO patients, it may fail or be technically unfeasible due to factors such as a common bile size, location of the stenosis and/or tumor, and altered anatomy. (9-11) Previous literature suggests that EUS-GB could be useful as a salvage approach in MDBO in patients when ERCP and EUS-CBD are unsuccessful or not feasible.(12-14) However, there is a paucity of research on the relative efficacy and safety profiles of EUS-GB versus EUS-CBD as a primary approach for direct access biliary drainage. In this observational matched cohort study, we present a multicenter experience of the comparative safety and efficacy of EUS-GB and EUS-CBD for MDBO. Methods Patients and study design This was a multicenter, retrospective observational study with all consecutive adult patients (age >18 years) in whom a EUS-GB and EUS-CBD was attempted for MDBO from January 2015 to October 2024 from two large US academic hospitals. This study was approved under IRB Protocol number 2003P001665. The inclusion criteria were: (I) Patients were considered to have MDBO if they had imaging findings of distal biliary obstruction secondary to malignancy involving the distal biliary system and failed standard ERCP (II) All patients had bilirubin > 3mg/dL. Patients with prior successful ERCP with biliary stent placement were excluded. The study was approved by our institutional review board. Our study adhered to the Strengthening the Reporting of Observations studies in Epidemiology (STROBE) checklist. Data collection and outcome measures Data regarding demographic, clinical, and procedural characteristics were collected for all patients. Technical success was defined as correct LAMS placement. Clinical success was defined according to the different clinical indications: (I) In patients with clinical symptoms of cholangitis; serum bilirubin level decrease of 50% or more within 1 weeks following the procedure of biliary drainage without recurrent cholangitis or biliary sepsis. (II) In patients with clinical jaundice; serum bilirubin level decrease of 50% or more within 1 weeks or <3 mg/dL at 2 weeks following the procedure of biliary drainage. Adverse events were classified either as intraprocedural, or as early or late, according to whether adverse events (AEs) occurred ≤24 h (early) and ≤30 days (late) after stent placement and were graded according to the American Society for Gastrointestinal Endoscopy lexicon (15). Cystic duct patency was defined as the absence of cystic duct obstruction on the most recent cross-sectional imaging either computed tomography (CT) or magnetic resonance imaging (MRI) prior the stent placement. The total procedure time was defined as the time from insertion to exit of the endoscope from the mouth of the patient. Re-intervention was defined as need for repeat biliary intervention for jaundice or cholangitis any time after the initial procedure for treatment of MDBO. Statistical analysis Data was analyzed using the R program version 4.3.1 (College Station, TX). Continuous variables were reported using mean ± standard deviation (SD) and median (range). Categorical variables were presented as frequency counts and percentages (%). Given the non-normal distribution of data, Chi-square and Fisher's exact tests were used for categorical variables, while the Mann-Whitney test was employed for continuous variables. Propensity score matching (1:1) was performed to balance key baseline characteristics, ensuring comparability between the groups (see below). To find predictors of procedural re-intervention, univariate and multivariate binary logistic regression analysis was used. The survival outcomes were analyzed by log-rank tests and Cox regression models, with statistical significance set at p < 0.05. Results A total of 82 patients with MDBO were included in this study. Of these, 22 patients (26.8%) underwent EUS-GB, and 60 patients (73.2%) underwent EUS-CBD. The overall technical success rate was 96.3% (79 of 82), with EUS-GB achieving success in 21 patients (95.5%) and EUS-CBD in 58 patients (96.7%), demonstrating comparable success rates between the two groups (p = 0.795). Among the EUS-GB cases, 17 showed cystic duct patency on cross-sectional imaging, with a technical success rate of 94.1% (16 of 17). Additionally, 11(50%) EUS-GB procedures were performed as salvage therapy due to the absence of a suitable target for direct biliary drainage into the CBD, achieving a technical success rate of 90.9% (10 of 11). Mean age of patients with successful LAMS placement was 69.75 ± 10.82 years, and 55.7% were female. Pancreatic cancer was the most common diagnosis (60.8%), followed by duodenal cancer (12.7%) and cholangiocarcinoma (6.3%). ( Table 1 ). The median follow-up period for patients in whom biliary drainage was successful was 116 (51-300) days. The mortality rate during follow-up was 82.3% (65 of 79), with 76.2% in EUS-GB group and 84.5% in EUS-CBD group (p = 0.506). Before propensity-score matching Of these 79 MDBO patients with successful LAMS placement, the overall clinical success was achieved 89.9% (71 of 79). Of these, clinical success was similar in both EUS-GB and EUS-CBD groups (87.9% [n=51] vs 95.2% [n=20], p=0.674). In terms of adverse events, both groups reported no (0%) intraoperative AEs. Early AEs occurred overall in 5.1% (n=4) of patient with similar rate in EUS-GB and EUS-CBD (9.5% [n=2] vs 3.4% [n=2], p=0.286). Early adverse events (those occurring <24 hours after procedure), classified according to the ASGE classification as 2 mild and 2 moderate included two cases of abdominal discomfort requiring prolonged hospitalization (mild), one case of bile leak necessitating interventional radiologic drainage (moderate), and one case of upper gastrointestinal bleeding associated with anticoagulant medication use (moderate). Overall late AEs were 8 (10.1%) with similar safety profile in EUS-GB and EUS-CBD group (10.3% vs 9.5%, p=1). Late AEs were 4 ascending cholangitis caused by food debris impaction, 1 biliary sump syndrome due to food debris, 1 cholecystitis, 1 post-ERCP pancreatitis, and 1 bacterial peritonitis. Repeat intervention was indicated in 13 (16.5%) patients with a significantly higher rate in EUS-CBD group compared to EUS-GB group (20.7% [n=12/58] vs 4.8% [n=1/21], p=0.002). In EUS-CBD group, the most common indication for repeat intervention was food debris impaction which caused either ascending cholangitis or increased liver function tests (11 patients) and 1 metal biliary stent migration. In EUS-GB group, 1 patient received external drainage due to biliary leak. All Median time to reintervention was 66 (13-181) days. For EUS-GB patients, 16 patients with cystic duct patency on cross-sectional imaging correlated with clinically successful biliary decompression rate of 93.8% (15 of 16). Only one (6.6%) of these patients who achieved clinical success needed repeat intervention. Univariable and multivariable analysis for reintervention Our univariable analysis revealed that late AEs were associated with higher reintervention rates with odds ratio (OR) of 4.675 (95%CI: 1.064 - 20.506, p = 0.02). In multivariable analysis, EUS-GB were associated with lower reintervention rates with adjusted OR of 0.122 (95%CI: 0.005 - 0.955, p<0.05) and 0.039 (95%CI: 0.002 - 0.428, p=0.013), respectively. ( Table 2 ) After propensity-score matching Propensity score matching (1:1) was conducted by sex, age, and BMI, resulting in 21 matched pairs for comparisons between the EUS-GB and EUS-CBD groups. The balance of baseline characteristics before and after propensity score matching is presented in Figure 1 . Clinical success was similar in both EUS-GB and EUS-CBD groups (95.2% vs 85.7%, p=0.61). 6-month reintervention rate was lower in the EUS-GB group compared to the EUS-CBD group (4.8% vs 23.8%, p=0.004). In terms of adverse events (AEs), EUS-GB and EUS-CBD showed similar safety profile on early AEs (9.5% vs 9.5%, p=1) and late AEs (9.5% vs 9.5%, p=1). Median procedural duration was 98 (47-210) minutes, shorter in EUS-GB group with 65 (29-170) minutes compared to EUS-CBD group with 120 (62-130) minutes. There was no difference in overall survival distributions between patients in the EUS-GB and EUS-CBD groups (log-rank test, p = 0.301). ( Figure 2 ) Discussion To the best of our knowledge, this is the first matched cohort study that compares the efficacy and safety of EUS-GB and EUS-CBD in patients with MDBO following failed ERCP. EUS-GB demonstrated comparable high technical success, clinical success, safety profiles, and overall survival distributions, with the added advantages of shorter procedural time, a lower 6-month reintervention rate compared to EUS-CBD, and lower rate of stent occlusion/cholangitis. In MDBO patients, ERCP failure can occur due to surgically altered anatomy, an inaccessible papilla caused by malignancy, or difficulties in cannulation. In response to these challenges, EUS-CBD, has emerged as a viable alternative to ERCP. EUS-CBD offers several advantages compared to alternative options like percutaneous biliary drainage, including internal drainage, the convenience of a single procedure performed by the single operator, and the elimination of discomfort associated with an external catheter. Compared to other approaches, EUS-CBD has been associated with higher clinical success rates, fewer post-procedure adverse events, and lower reintervention rates (16). Previous meta-analysis showed EUS-guided biliary drainage was associated with lower rates of post-procedure pancreatitis with relative risk (RR) of 0.12 (95% CI 0.02-0.62), stent dysfunction with RR of 0.54 (95% CI 0.32-0.91), and tumor ingrowth with RR of 0.22 (95% CI 0.07-0.76) compared to ERCP for primary treatment of MDBO. Although EUS-CBD demonstrates a high technical success rate and a favorable safety profile in these patients, it can be unsuccessful or technically difficult in cases involving a common bile duct smaller than 15 mm or other anatomical alterations (9-11). EUS-GB, which was initially performed for treatment of cholecystitis, was subsequently adapted as a potential internal salvage therapy for patients in whom EUS-CBD could not technically be performed. A previous multicenter study reported on 48 EUS-GB patients who underwent LAMS placement as a rescue treatment for MDBO, achieving a technical success rate of 100% and a clinical success rate of 81.3%. AEs, classified according to ASGE criteria, were observed in 5 (10.4%) patients, including 2 mild and 3 moderate AEs. The mean follow-up duration was 122 days.(17) Another multicenter study demonstrated a technical success rate of 100% and a clinical success rate of 93%. AEs were observed in 5 (18%) patients. Common AEs reported in previous studies included food debris impaction, bleeding, and gallbladder ulceration.(18) These findings from previous literature align with the results from our cohort, demonstrating similarly high rates of technical and clinical success, as well as low occurrence of AEs and types of AEs. Our study demonstrated that the primary reason for reintervention in EUS-CBD was ascending cholangitis, secondary to food debris impaction. Notably, the EUS-GB group had a significantly lower reintervention rate and no instances of reintervention for stent occlusion causing cholangitis. We hypothesize that this intriguing finding may be (I) attributed to LAMS occlusion, which tends to result from large fibrous food debris. Since the cystic duct is smaller than the common bile duct, large debris are less likely to become lodged within it. Moreover, utilizing the gallbladder as a buffer with a smaller conduit to drain the bile duct might provide an additional drainage buffer, reducing the likelihood of occlusion (II) EUS-GB is performed at a location farther from the tumor site, reducing the risk of progressive local invasion or compression at the LAMS placement site compared to EUS-CBD, which is conducted closer to the tumor. In our cohort, 49 patients presented with duodenal stenosis concomitant with MDBO. Among them, EUS-CBD was performed in 36 patients, with 10 (27.7%) requiring reintervention, while EUS-GB was performed in 13 patients, with only 1 (7.7%) requiring reintervention. These findings may suggest that EUS-CBD should be avoided, and EUS-GB may be a more favorable option for MDBO patients particularly in those with duodenal stenosis. Cystic duct patency appears to be a critical prerequisite for the successful implementation of EUS-GB in patients with MDBO. Patency ensures the unobstructed flow of bile from the gallbladder into the common bile duct, facilitating effective drainage after stent placement. In our study, 17 patients who underwent EUS-GB had confirmed cystic duct patency on imaging prior to the procedure, achieving a clinical success rate of 94.1%. This factor likely plays a key role in the observed technical and clinical success rates, as it minimizes the risk of stent occlusion and allows for optimal biliary drainage. Therefore, assessing cystic duct patency should be an essential step in patient selection to improve outcomes and reduce the likelihood of reintervention. Future studies should further evaluate the role of confirming cystic duct patency using prior imaging (CT or MRI) or intraprocedural cholecystography as an inclusion criterion for EUS-GB to establish standardized guidelines for its use. The similar efficacy of EUS-GB, whether performed as an upfront procedure or as a salvage therapy following unsuccessful EUS-CBD, highlights its reliability as a treatment option for MDBO patients. In our study, 11 patients (50%) in the EUS-GB group underwent the procedure as a salvage therapy for EUS-CBD due to the absence of a suitable target for direct biliary drainage into the CBD. All these patients showed cystic duct patency on imaging prior to stent placement. The promising results demonstrated that EUS-GB as a primary approach and those requiring it as a salvage procedure had similar efficacy, with comparable rates of technical success (90.9% vs. 100%, p = 1), clinical success (90.9% vs. 100%, p = 1), and reintervention (90% vs. 100%, p = 0.47). These findings suggest that EUS-GB is a robust alternative for biliary drainage, regardless of whether it is used as the initial method or as a rescue strategy. This underscores the importance of considering EUS-GB in cases where EUS-CBD may not be feasible or has failed, without compromising the effectiveness of the intervention. This study has a few limitations. First, our study was retrospective design and a multicenter approach, involving teams from two centers. Management strategies and procedural choices varied across centers, as these decisions were left to the discretion of the operators, which we could not standardize. To minimize biases, we applied propensity score matching to balance baseline characteristics between the two groups. Second, in the EUS-GB group, only one patient required reintervention, with the time to reintervention being just only one day. This might have led to an underestimation of the safety profile of EUS-GB. Further studies are needed to evaluate the long-term safety profile and time to reintervention for both interventions. In conclusion, our findings suggest EUS-GB is at least equivalent to EUS-CBD and may be preferable as a first-line direct biliary access approach for MDBO given lower re-intervention rate. Technical success remains high if EUS-GB is used as a salvage for EUS-CBD or as a primary approach for MDBO. Cystic duct patency on pre-procedural cross-sectional imaging correlated with clinically successful biliary decompression by EUS-GB. Further randomize controlled trials on efficacy and safety of EUS-GB and EUS-CBD are warranted to confirm our findings prior to considering EUS-GB for treatment of MDBO. Conclusion EUS-GB is a technically effective and clinically comparable alternative to EUS-CDS for MDBO, with significantly fewer reinterventions and stent-related complications. When cystic duct patency is confirmed on imaging, EUS-GB may be considered as a primary approach or salvage strategy for biliary drainage in MDBO. Abbreviations ACG American College of Gastroenterology AEs Adverse events ASGE American Society of Gastrointestinal Endoscopy CI Confidence interval CT Computed tomography ERCP Endoscopic retrograde cholangiopancreatography ESGE European Society of Gastrointestinal Endoscopy EUS Endoscopic ultrasound EUS-CBD Endoscopic ultrasound-guided choledochoduodenostomy EUS-GB Endoscopic ultrasound-guided gallbladder drainage LAMS Lumen-apposing metal stents MDBO Malignant distal biliary obstruction MRI Magnetic resonance imaging OR Odds ratio PT-GB Percutaneous gallbladder drainage RR Relative risk SD Standard deviation STROBE Strengthening the Reporting of Observations studies in Epidemiology Declarations Funding: None Conflict of interests statement for all authors: N.S. has no conflict of interest. C.T. has served as a consultant for Apollo Endosurgery, Boston Scientific, Enterasense, EnVision Endoscopy, Fractyl, USGI Medical, Medtronic/Covidien, Olympus/Spiration and GI Dynamics, has served as an advisory boards member for USGI Medical and Fractyl, has received research grant and support from USGI Medical, Apollo Endosurgery, Boston Scientific, ERBE, FujiFilm, Lumendi Olympus/Spiration, Aspire Bariatrics and GI Dynamics, has served as a general partners for Blueframe Healthcare, has served as a founder for Enterasense, EnVision Endoscopy and GI Windows, and holds stock and royalties for GI Windows. M.R. has served as cofounder and consultant for EnteraSense and GI Windows Surgical; has served as consultant and received study support from Boston Scientific, Cook Medical and Olympus; has served as consultant and advisory board member for FujiFilm. S.S. is a scientific advisor to Microvitality, Inc. 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Supplementary Files Tables.docx Cite Share Download PDF Status: Published Journal Publication published 24 Sep, 2025 Read the published version in Digestive Diseases and Sciences → Version 1 posted Editorial decision: Revision requested 04 Aug, 2025 Reviews received at journal 30 Jul, 2025 Reviews received at journal 26 Jul, 2025 Reviewers agreed at journal 16 Jul, 2025 Reviewers agreed at journal 15 Jul, 2025 Reviewers agreed at journal 14 Jul, 2025 Reviewers invited by journal 10 Jul, 2025 Editor assigned by journal 04 Jul, 2025 Submission checks completed at journal 03 Jul, 2025 First submitted to journal 02 Jul, 2025 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. 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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-7032356","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":484648966,"identity":"ea46cdf1-b963-4219-8458-4aa169e047fe","order_by":0,"name":"Noppachai Siranart","email":"","orcid":"","institution":"Brigham and Women's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Noppachai","middleName":"","lastName":"Siranart","suffix":""},{"id":484648967,"identity":"e5766775-76c5-4e8d-903e-197b1406da49","order_by":1,"name":"Christopher Thompson","email":"","orcid":"","institution":"Brigham and Women's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Christopher","middleName":"","lastName":"Thompson","suffix":""},{"id":484648968,"identity":"e19f4eb4-620d-4c37-ac05-a7c7c3a8f5c6","order_by":2,"name":"Marvin Ryou","email":"","orcid":"","institution":"Brigham and Women's Hospital","correspondingAuthor":false,"prefix":"","firstName":"Marvin","middleName":"","lastName":"Ryou","suffix":""},{"id":484648969,"identity":"d01978cc-7606-4003-919c-19c5c48bf14e","order_by":3,"name":"Steven Steinway","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABDUlEQVRIiWNgGAWjYLCCBBDB3sPAzMBwACLCw8DA2IBTPTNUC88ZUrSAgUQOkVrk+88ffPBwx2F5g5tvj0kXMNyRN5+R/OzDGwYb2Q0HsGsxuJHMbJB45rDhhtt5adIzGJ4ZzrmRZjxzDkOaMU4tEsxsEolttxk33M4xu83DcJhxBs8BY2YgIxGXFvn+w+w/gFrsN9w8A9ZiP4Pn+Geglv84tTAcSGZjAGpJ3HCDB6wlcQZ7D8iWAzi1AP1iDHTY/+SZZ/LSf/MYHE4GailmnGOQbDwTp8MOPvz4sy3Ntu/42cPGPBWHbWcws29meFNhJ9uHy2EwoABWYAC3nYBysHUNRCgaBaNgFIyCkQkAAp5kINfMutQAAAAASUVORK5CYII=","orcid":"","institution":"Brigham and Women's Hospital","correspondingAuthor":true,"prefix":"","firstName":"Steven","middleName":"","lastName":"Steinway","suffix":""}],"badges":[],"createdAt":"2025-07-02 20:08:05","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7032356/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7032356/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s10620-025-09417-w","type":"published","date":"2025-09-24T15:58:09+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":86767370,"identity":"5963fb5c-87b9-47b6-a573-20843999fd4c","added_by":"auto","created_at":"2025-07-15 11:11:48","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":77403,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePropensity matching characteristics in the EUS-guided gall bladder drainage (EUS-GB) and EUS-guided choledochoduodenostomy (EUS-CBD) cohorts \u003c/strong\u003eA) Mean of each covariate and estimated propensity score by procedure type after propensity score matching for age (left) and BMI (right). B) Balance in propensity score and all covariates before and after matching (C) distribution of propensity score in the matched treated group (EUS-GB), matched control group (EUS-CBD) and the unmatched control group.\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7032356/v1/3faa9760192c19d12d12cb5e.jpg"},{"id":86767368,"identity":"03e50c49-56af-45fe-a45f-2d6d0b8288d7","added_by":"auto","created_at":"2025-07-15 11:11:48","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":50018,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eComparison of overall survival between EUS-GB and EUS-CBD.\u003c/strong\u003e Overall survival after endoscopic decompression of malignant distal biliary obstruction (MDBO) with EUS-guided gall bladder drainage (EUS-GB) and EUS-guided choledochoduodenostomy (EUS-CBD) was evaluated. There was no clinically significant difference in overall survival between these two groups.\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7032356/v1/107343741ec875962a4c3a4d.jpg"},{"id":92430578,"identity":"0896759a-e07f-45a4-90a7-bc8e012c9f64","added_by":"auto","created_at":"2025-09-29 16:06:07","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":621845,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7032356/v1/cbd78567-c59d-4f14-9c0a-491fccce8cde.pdf"},{"id":86767372,"identity":"105941b5-0716-4f68-afb7-ec0574d5d5e0","added_by":"auto","created_at":"2025-07-15 11:11:48","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":129261,"visible":true,"origin":"","legend":"","description":"","filename":"Tables.docx","url":"https://assets-eu.researchsquare.com/files/rs-7032356/v1/fbaab9bd9a1770f87a4ab751.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Endoscopic Choledochoduodenostomy versus Gallbladder Drainage for Malignant Biliary Obstruction: A Propensity Score Matched Study","fulltext":[{"header":"Introduction","content":"\u003cp\u003eBiliary drainage is recommended for patients with biliary tract obstruction, which may be caused by malignant distal biliary obstruction (MDBO), regardless of the presence of infection. According to a joint statement released by multiple gastrointestinal societies, including the American College of Gastroenterology (ACG), the American Society of Gastrointestinal Endoscopy (ASGE), and the European Society of Gastrointestinal Endoscopy (ESGE), endoscopic retrograde cholangiopancreatography (ERCP) remains the primary interventional approach for obstructive jaundice. With a failure rate of up to 10\u0026ndash;20% for MDBO, interventional radiology techniques or endoscopic ultrasound (EUS)-guided biliary drainage are considered alternative options in cases of failed ERCP. Such failures may be attributed to factors including duodenal stenosis, tumor encroachment around the papilla, or challenges in biliary cannulation (1-3). Previous multicenter RCT demonstrated EUS-guided choledochoduodenostomy (EUS-CBD) was associated with higher technical success and shorter procedural time than ERCP in unresectable MDBO patients.(4) Due to its high technical feasibility and efficacy, EUS-CBD with lumen-apposing metal stents (LAMS) for biliary drainage has emerged as an alternative approach for patients in whom ERCP has failed.\u003c/p\u003e\n\u003cp\u003eWith the emergence of endoscopic ultrasound-guided gallbladder drainage (EUS-GB), this technique has been introduced as an alternative to percutaneous gallbladder drainage (PT-GB) for biliary drainage in patients with acute cholecystitis who have significant comorbidities and are considered unfit for surgery. However, long-term PT-GB is associated with tube dysfunction, pain, bile leak, readmission, and the necessity for reintervention.(5, 6) EUS-GB has less overall adverse events, shorter hospital stays and unplanned reinterventions, and readmissions compared with PT-GB in acute cholecystitis.(7, 8) While EUS-CBD demonstrates a high technical success rate and a favorable risk profile in MDBO patients, it may fail or be technically unfeasible due to factors such as a common bile size, location of the stenosis and/or tumor, and altered anatomy. (9-11) Previous literature suggests that EUS-GB could be useful as a salvage approach in MDBO in patients when ERCP and EUS-CBD are unsuccessful or not feasible.(12-14)\u003c/p\u003e\n\u003cp\u003eHowever, there is a paucity of research on the relative efficacy and safety profiles of EUS-GB versus EUS-CBD as a primary approach for direct access biliary drainage. In this observational matched cohort study, we present a multicenter experience of \u0026nbsp;the comparative safety and efficacy of EUS-GB and EUS-CBD for MDBO. \u0026nbsp;\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cem\u003ePatients and study design\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThis was a multicenter, retrospective observational study with all consecutive adult patients (age \u0026gt;18 years) in whom a EUS-GB and EUS-CBD was attempted for MDBO from January 2015 to October 2024 from two large US academic hospitals. This study was approved under IRB Protocol number 2003P001665. The inclusion criteria were: (I) Patients were considered to have MDBO if they had imaging findings of distal biliary obstruction secondary to malignancy involving the distal biliary system and failed standard ERCP (II) All patients had bilirubin \u0026gt; 3mg/dL. Patients with prior successful ERCP with biliary stent placement were excluded. The study was approved by our institutional review board. Our study adhered to the Strengthening the Reporting of Observations studies in Epidemiology (STROBE) checklist.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eData collection and outcome measures\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eData regarding demographic, clinical, and procedural characteristics were collected for all patients. Technical success was defined as correct LAMS placement. Clinical success was defined according to the different clinical indications: (I) In patients with clinical symptoms of cholangitis; serum bilirubin level decrease of 50% or more within 1 weeks following the procedure of biliary drainage without recurrent cholangitis or biliary sepsis. (II) In patients with clinical jaundice; serum bilirubin level decrease of 50% or more within 1 weeks or \u0026lt;3 mg/dL at 2 weeks following the procedure of biliary drainage. Adverse events were classified either as intraprocedural, or as early or late, according to whether adverse events (AEs) occurred ≤24 h (early) and ≤30 days (late) after stent placement and were graded according to the American Society for Gastrointestinal Endoscopy lexicon\u0026nbsp;(15). Cystic duct patency was defined as the absence of cystic duct obstruction on the most recent cross-sectional imaging either computed tomography (CT) or magnetic resonance imaging (MRI) prior the stent placement. The total procedure time was defined as the time from insertion to exit of the endoscope from the mouth of the patient. Re-intervention was defined as need for repeat biliary intervention for jaundice or cholangitis any time after the initial procedure for treatment of MDBO.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStatistical analysis\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eData was analyzed using the R program version 4.3.1 (College Station, TX). Continuous variables were reported using mean ± standard deviation (SD) and median (range). Categorical variables were presented as frequency counts and percentages (%). Given the non-normal distribution of data, Chi-square and Fisher's exact tests were used for categorical variables, while the Mann-Whitney test was employed for continuous variables. Propensity score matching (1:1) was performed to balance key baseline characteristics, ensuring comparability between the groups (see below). To find predictors of procedural re-intervention, univariate and multivariate binary logistic regression analysis was used. The survival outcomes were analyzed by log-rank tests and Cox regression models, with statistical significance set at p \u0026lt; 0.05.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 82 patients with MDBO were included in this study. Of these, 22 patients (26.8%) underwent EUS-GB, and 60 patients (73.2%) underwent EUS-CBD. The overall technical success rate was 96.3% (79 of 82), with EUS-GB achieving success in 21 patients (95.5%) and EUS-CBD in 58 patients (96.7%), demonstrating comparable success rates between the two groups (p = 0.795). Among the EUS-GB cases, 17 showed cystic duct patency on cross-sectional imaging, with a technical success rate of 94.1% (16 of 17). Additionally, 11(50%) EUS-GB procedures were performed as salvage therapy due to the absence of a suitable target for direct biliary drainage into the CBD, achieving a technical success rate of 90.9% (10 of 11). Mean age of patients with successful LAMS placement was 69.75 ± 10.82 years, and 55.7% were female. Pancreatic cancer was the most common diagnosis (60.8%), followed by duodenal cancer (12.7%) and cholangiocarcinoma (6.3%). (\u003cstrong\u003e\u003cu\u003eTable 1\u003c/u\u003e\u003c/strong\u003e). The median follow-up period for patients in whom biliary drainage was successful was 116 (51-300) days. The mortality rate during follow-up was 82.3% (65 of 79), with 76.2% in EUS-GB group and 84.5% in EUS-CBD group (p = 0.506).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eBefore propensity-score matching\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOf these 79 MDBO patients with successful LAMS placement, the overall clinical success was achieved 89.9% (71 of 79). Of these, clinical success was similar in both EUS-GB and EUS-CBD groups (87.9% [n=51] vs 95.2% [n=20], p=0.674). In terms of adverse events, both groups reported no (0%) intraoperative AEs. Early AEs occurred overall in 5.1% (n=4) of patient with similar rate in EUS-GB and EUS-CBD (9.5% [n=2] vs 3.4% [n=2], p=0.286). Early adverse events (those occurring \u0026lt;24 hours after procedure), classified according to the ASGE classification as 2 mild and 2 moderate included two cases of abdominal discomfort requiring prolonged hospitalization (mild), one case of bile leak necessitating interventional radiologic drainage (moderate), and one case of upper gastrointestinal bleeding associated with anticoagulant medication use (moderate). Overall late AEs were 8 (10.1%) with similar safety profile in EUS-GB and EUS-CBD group (10.3% vs 9.5%, p=1). Late AEs were 4 ascending cholangitis caused by food debris impaction, 1 biliary sump syndrome due to food debris, 1 cholecystitis, 1 post-ERCP pancreatitis, and 1 bacterial peritonitis. Repeat intervention was indicated in 13 (16.5%) patients with a significantly higher rate in EUS-CBD group compared to EUS-GB group (20.7% [n=12/58] vs 4.8% [n=1/21], p=0.002). In EUS-CBD group, the most common indication for repeat intervention was food debris impaction which caused either ascending cholangitis or increased liver function tests (11 patients) and 1 metal biliary stent migration. In EUS-GB group, 1 patient received external drainage due to biliary leak. All Median time to reintervention was 66 (13-181) days.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor EUS-GB patients, 16 patients with cystic duct patency on cross-sectional imaging correlated with clinically successful biliary decompression rate of 93.8% (15 of 16). Only one (6.6%) of these patients who achieved clinical success needed repeat intervention.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eUnivariable and multivariable analysis for reintervention\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOur univariable analysis revealed that late AEs were associated with higher reintervention rates with odds ratio (OR) of 4.675 (95%CI: 1.064 - 20.506, p = 0.02). In multivariable analysis, EUS-GB were associated with lower reintervention rates with adjusted OR of 0.122 (95%CI: 0.005 - 0.955, p\u0026lt;0.05) and 0.039 (95%CI: 0.002 - 0.428, p=0.013), respectively.\u0026nbsp;(\u003cstrong\u003e\u003cu\u003eTable 2\u003c/u\u003e\u003c/strong\u003e)\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAfter propensity-score matching\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePropensity score matching (1:1) was conducted by sex, age, and BMI, resulting in 21 matched pairs for comparisons between the EUS-GB and EUS-CBD groups. The balance of baseline characteristics before and after propensity score matching is presented in \u003cstrong\u003e\u003cu\u003eFigure 1\u003c/u\u003e\u003c/strong\u003e. Clinical success was similar in both EUS-GB and EUS-CBD groups (95.2% vs 85.7%, p=0.61). 6-month reintervention rate was lower in the EUS-GB group compared to the EUS-CBD group (4.8% vs 23.8%, p=0.004). In terms of adverse events (AEs), EUS-GB and EUS-CBD showed similar safety profile on early AEs (9.5% vs 9.5%, p=1) and late AEs (9.5% vs 9.5%, p=1). Median procedural duration was 98 (47-210) minutes,\u0026nbsp;shorter in EUS-GB group with 65 (29-170) minutes\u0026nbsp;compared to EUS-CBD group with 120 (62-130) minutes. There was no difference in overall survival distributions between patients in the EUS-GB and EUS-CBD groups (log-rank test, p = 0.301). (\u003cstrong\u003e\u003cu\u003eFigure 2\u003c/u\u003e\u003c/strong\u003e)\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eTo the best of our knowledge, this is the first matched cohort study that compares the efficacy and safety of EUS-GB and EUS-CBD in patients with MDBO following failed ERCP. EUS-GB demonstrated comparable high technical success, clinical success, safety profiles, and overall survival distributions, with the added advantages of shorter procedural time, a lower 6-month reintervention rate compared to EUS-CBD, and lower rate of stent occlusion/cholangitis.\u003c/p\u003e\n\u003cp\u003eIn MDBO patients, ERCP failure can occur due to surgically altered anatomy, an inaccessible papilla caused by malignancy, or difficulties in cannulation. In response to these challenges, EUS-CBD, has emerged as a viable alternative to ERCP. EUS-CBD offers several advantages compared to alternative options like percutaneous biliary drainage, including internal drainage, the convenience of a single procedure performed by the single operator, and the elimination of discomfort associated with an external catheter. Compared to other approaches, EUS-CBD has been associated with higher clinical success rates, fewer post-procedure adverse events, and lower reintervention rates (16). Previous meta-analysis showed EUS-guided biliary drainage was associated with lower rates of post-procedure pancreatitis with relative risk (RR) of 0.12 (95% CI 0.02-0.62), stent dysfunction with RR of 0.54 (95% CI 0.32-0.91), and tumor ingrowth with RR of 0.22 (95% CI 0.07-0.76) compared to ERCP for primary treatment of MDBO. Although\u0026nbsp;EUS-CBD demonstrates a high technical success rate and a favorable safety profile in these patients, it can be unsuccessful or technically difficult in cases involving a common bile duct smaller than 15 mm or other anatomical alterations\u0026nbsp;(9-11).\u003c/p\u003e\n\u003cp\u003eEUS-GB, which was initially performed for treatment of cholecystitis, was subsequently adapted as a potential internal salvage \u0026nbsp;therapy for patients in whom EUS-CBD could not technically be performed. A previous multicenter study reported on 48 EUS-GB patients who underwent LAMS placement as a rescue treatment for MDBO, achieving a technical success rate of 100% and a clinical success rate of 81.3%. AEs, classified according to ASGE criteria, were observed in 5 (10.4%) patients, including 2 mild and 3 moderate AEs. The mean follow-up duration was 122 days.(17) Another multicenter study demonstrated a technical success rate of 100% and a clinical success rate of 93%. AEs were observed in 5 (18%) patients. Common AEs reported in previous studies included food debris impaction, bleeding, and gallbladder ulceration.(18) These findings from previous literature align with the results from our cohort, demonstrating similarly high rates of technical and clinical success, as well as low occurrence of AEs and types of AEs.\u003c/p\u003e\n\u003cp\u003eOur study demonstrated that the primary reason for reintervention in EUS-CBD was ascending cholangitis, secondary to food debris impaction. Notably, the EUS-GB group had a significantly lower reintervention rate and no instances of reintervention for stent occlusion causing cholangitis. We hypothesize that this intriguing finding may be (I) attributed to LAMS occlusion, which tends to result from large fibrous food debris. Since the cystic duct is smaller than the common bile duct, large debris are less likely to become lodged within it. Moreover, utilizing the gallbladder as a buffer with a smaller conduit to drain the bile duct might provide an additional drainage buffer, reducing the likelihood of occlusion (II) EUS-GB is performed at a location farther from the tumor site, reducing the risk of progressive local invasion or compression at the LAMS placement site compared to EUS-CBD, which is conducted closer to the tumor. In our cohort, 49 patients presented with duodenal stenosis concomitant with MDBO. Among them, EUS-CBD was performed in 36 patients, with 10 (27.7%) requiring reintervention, while EUS-GB was performed in 13 patients, with only 1 (7.7%) requiring reintervention. These findings may suggest that EUS-CBD should be avoided, and EUS-GB may be a more favorable option for MDBO patients particularly in those with duodenal stenosis.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCystic duct patency appears to be a critical prerequisite for the successful implementation of EUS-GB in patients with MDBO. Patency ensures the unobstructed flow of bile from the gallbladder into the common bile duct, facilitating effective drainage after stent placement. In our study, 17 patients who underwent EUS-GB had confirmed cystic duct patency on imaging prior to the procedure, achieving a clinical success rate of 94.1%. This factor likely plays a key role in the observed technical and clinical success rates, as it minimizes the risk of stent occlusion and allows for optimal biliary drainage. Therefore, assessing cystic duct patency should be an essential step in patient selection to improve outcomes and reduce the likelihood of reintervention. Future studies should further evaluate the role of confirming cystic duct patency using prior imaging (CT or MRI) or intraprocedural cholecystography as an inclusion criterion for EUS-GB to establish standardized guidelines for its use.\u003c/p\u003e\n\u003cp\u003eThe similar efficacy of EUS-GB, whether performed as an upfront procedure or as a salvage therapy following unsuccessful EUS-CBD, highlights its reliability as a treatment option for MDBO patients. In our study, 11 patients (50%) in the EUS-GB group underwent the procedure as a salvage therapy for EUS-CBD due to the absence of a suitable target for direct biliary drainage into the CBD. All these patients showed cystic duct patency on imaging prior to stent placement. The promising results demonstrated that EUS-GB as a primary approach and those requiring it as a salvage procedure had similar efficacy, with comparable rates of technical success (90.9% vs. 100%, p = 1), clinical success (90.9% vs. 100%, p = 1), and reintervention (90% vs. 100%, p = 0.47). These findings suggest that EUS-GB is a robust alternative for biliary drainage, regardless of whether it is used as the initial method or as a rescue strategy. This underscores the importance of considering EUS-GB in cases where EUS-CBD may not be feasible or has failed, without compromising the effectiveness of the intervention.\u003c/p\u003e\n\u003cp\u003eThis study has a few limitations. First, our study was retrospective design and a multicenter approach, involving teams from two centers. Management strategies and procedural choices varied across centers, as these decisions were left to the discretion of the operators, which we could not standardize. To minimize biases, we applied propensity score matching to balance baseline characteristics between the two groups. Second, in the EUS-GB group, only one patient required reintervention, with the time to reintervention being just only one day. This might have led to an underestimation of the safety profile of EUS-GB. Further studies are needed to evaluate the long-term safety profile and time to reintervention for both interventions.\u003c/p\u003e\n\u003cp\u003eIn conclusion, our findings suggest EUS-GB is at least equivalent to EUS-CBD and may be preferable as a first-line direct biliary access approach for MDBO given lower re-intervention rate. Technical success remains high if EUS-GB is used as a salvage for EUS-CBD or as a primary approach for MDBO. Cystic duct patency on pre-procedural cross-sectional imaging correlated with clinically successful biliary decompression by EUS-GB. Further randomize controlled trials on efficacy and safety of EUS-GB and EUS-CBD are warranted to confirm our findings prior to considering EUS-GB for treatment of MDBO.\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eEUS-GB is a technically effective and clinically comparable alternative to EUS-CDS for MDBO, with significantly fewer reinterventions and stent-related complications. When cystic duct patency is confirmed on imaging, EUS-GB may be considered as a primary approach or salvage strategy for biliary drainage in MDBO.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eACG\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;American College of Gastroenterology\u003c/p\u003e\n\u003cp\u003eAEs\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Adverse events\u003c/p\u003e\n\u003cp\u003eASGE\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;American Society of Gastrointestinal Endoscopy\u003c/p\u003e\n\u003cp\u003eCI\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Confidence interval\u003c/p\u003e\n\u003cp\u003eCT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Computed tomography\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eERCP\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Endoscopic retrograde cholangiopancreatography\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eESGE\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;European Society of Gastrointestinal Endoscopy\u003c/p\u003e\n\u003cp\u003eEUS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Endoscopic ultrasound\u003c/p\u003e\n\u003cp\u003eEUS-CBD\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Endoscopic ultrasound-guided choledochoduodenostomy\u003c/p\u003e\n\u003cp\u003eEUS-GB\u0026nbsp;Endoscopic ultrasound-guided gallbladder drainage\u003c/p\u003e\n\u003cp\u003eLAMS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Lumen-apposing metal stents\u003c/p\u003e\n\u003cp\u003eMDBO\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Malignant distal biliary obstruction\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMRI\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Magnetic resonance imaging\u003c/p\u003e\n\u003cp\u003eOR\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Odds ratio\u003c/p\u003e\n\u003cp\u003ePT-GB\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Percutaneous gallbladder drainage\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRR Relative risk\u003c/p\u003e\n\u003cp\u003eSD\u003cstrong\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/strong\u003eStandard deviation\u003c/p\u003e\n\u003cp\u003eSTROBE\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003eStrengthening the Reporting of Observations studies in Epidemiology\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e None\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interests statement for all authors:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eN.S. has no conflict of interest.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eC.T. has served as a consultant for Apollo Endosurgery, Boston Scientific, Enterasense, EnVision Endoscopy, Fractyl, USGI Medical, Medtronic/Covidien, Olympus/Spiration and GI Dynamics, has served as an advisory boards member for USGI Medical and Fractyl, has received research grant and support from USGI Medical, Apollo Endosurgery, Boston Scientific, ERBE, FujiFilm, Lumendi Olympus/Spiration, Aspire Bariatrics and GI Dynamics, has served as a general partners for Blueframe Healthcare, has served as a founder for Enterasense, EnVision Endoscopy and GI Windows, and holds stock and royalties for GI Windows.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eM.R. has served as cofounder and consultant for EnteraSense and GI Windows Surgical; has served as consultant and received study support from Boston Scientific, Cook Medical and Olympus; has served as consultant and advisory board member for FujiFilm.\u003c/p\u003e\n\u003cp\u003eS.S. is a scientific advisor to Microvitality, Inc.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions:\u003c/strong\u003e All authors had access to the data and a role in writing the manuscript\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eElmunzer BJ, Maranki JL, G\u0026oacute;mez V, Tavakkoli A, Sauer BG, Limketkai BN, et al. ACG Clinical Guideline: Diagnosis and Management of Biliary Strictures. Am J Gastroenterol. 2023;118(3):405-26.\u003c/li\u003e\n\u003cli\u003ePawa S, Marya NB, Thiruvengadam NR, Ngamruengphong S, Baron TH, Bun Teoh AY, et al. American Society for Gastrointestinal Endoscopy guideline on the role of therapeutic EUS in the management of biliary tract disorders: summary and recommendations. Gastrointest Endosc. 2024;100(6):967-79.\u003c/li\u003e\n\u003cli\u003eDumonceau JM, Tringali A, Papanikolaou IS, Blero D, Mangiavillano B, Schmidt A, et al. Endoscopic biliary stenting: indications, choice of stents, and results: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline - Updated October 2017. Endoscopy. 2018;50(9):910-30.\u003c/li\u003e\n\u003cli\u003eTeoh AYB, Napoleon B, Kunda R, Arcidiacono PG, Kongkam P, Larghi A, et al. EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial). Gastroenterology. 2023;165(2):473-82.e2.\u003c/li\u003e\n\u003cli\u003eMcKay A, Abulfaraj M, Lipschitz J. Short- and long-term outcomes following percutaneous cholecystostomy for acute cholecystitis in high-risk patients. Surg Endosc. 2012;26(5):1343-51.\u003c/li\u003e\n\u003cli\u003eLee SS, Park DH, Hwang CY, Ahn CS, Lee TY, Seo DW, et al. EUS-guided transmural cholecystostomy as rescue management for acute cholecystitis in elderly or high-risk patients: a prospective feasibility study. Gastrointest Endosc. 2007;66(5):1008-12.\u003c/li\u003e\n\u003cli\u003eCucchetti A, Binda C, Dajti E, Sbrancia M, Ercolani G, Fabbri C. Trial sequential analysis of EUS-guided gallbladder drainage versus percutaneous cholecystostomy in patients with acute cholecystitis. Gastrointest Endosc. 2022;95(3):399-406.\u003c/li\u003e\n\u003cli\u003eLuk SW, Irani S, Krishnamoorthi R, Wong Lau JY, Wai Ng EK, Teoh AY. Endoscopic ultrasound-guided gallbladder drainage versus percutaneous cholecystostomy for high risk surgical patients with acute cholecystitis: a systematic review and meta-analysis. Endoscopy. 2019;51(8):722-32.\u003c/li\u003e\n\u003cli\u003ePaik WH, Lee TH, Park DH, Choi JH, Kim SO, Jang S, et al. EUS-Guided Biliary Drainage Versus ERCP for the Primary Palliation of Malignant Biliary Obstruction: A Multicenter Randomized Clinical Trial. Am J Gastroenterol. 2018;113(7):987-97.\u003c/li\u003e\n\u003cli\u003ePark JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, et al. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018;88(2):277-82.\u003c/li\u003e\n\u003cli\u003eBishay K, Boyne D, Yaghoobi M, Khashab MA, Shorr R, Ichkhanian Y, et al. Endoscopic ultrasound-guided transmural approach versus ERCP-guided transpapillary approach for primary decompression of malignant biliary obstruction: a meta-analysis. Endoscopy. 2019;51(10):950-60.\u003c/li\u003e\n\u003cli\u003eIssa D, Irani S, Law R, Shah S, Bhalla S, Mahadev S, et al. Endoscopic ultrasound-guided gallbladder drainage as a rescue therapy for unresectable malignant biliary obstruction: a multicenter experience. Endoscopy. 2021;53(8):827-31.\u003c/li\u003e\n\u003cli\u003eBinda C, Anderloni A, Fugazza A, Amato A, de Nucci G, Redaelli A, et al. EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience. Gastrointest Endosc. 2023;98(5):765-73.\u003c/li\u003e\n\u003cli\u003eRajadurai A, Zorron Cheng Tao Pu L, Cameron R, Tagkalidis P, Holt B, Bassan M, et al. Endoscopic ultrasound-guided gallbladder and bile duct drainage with lumen apposing metal stent: A large multicenter cohort (with videos). J Gastroenterol Hepatol. 2022;37(1):179-89.\u003c/li\u003e\n\u003cli\u003eCotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010;71(3):446-54.\u003c/li\u003e\n\u003cli\u003eMarx M, Caillol F, Autret A, Ratone JP, Zemmour C, Boher JM, et al. EUS-guided hepaticogastrostomy in patients with obstructive jaundice after failed or impossible endoscopic retrograde drainage: A multicenter, randomized phase II Study. Endosc Ultrasound. 2022;11(6):495-502.\u003c/li\u003e\n\u003cli\u003eBinda C, Anderloni A, Fugazza A, Amato A, de Nucci G, Redaelli A, et al. EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience. Gastrointestinal Endoscopy. 2023;98(5):765-73.\u003c/li\u003e\n\u003cli\u003eChang JI, Dong E, Kwok KK. Endoscopic ultrasound-guided transmural gallbladder drainage in malignant obstruction using a novel lumen-apposing stent: a case series (with video). Endosc Int Open. 2019;7(5):E655-e61.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 and 2 are navailable in the Supplementary Files section.\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":"direct access biliary drainage, choledochoduodenostomy, endoscopic ultrasound guided gallbladder drainage, malignant biliary obstruction, endoscopic ultrasound","lastPublishedDoi":"10.21203/rs.3.rs-7032356/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7032356/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction:\u003c/strong\u003e Endoscopic ultrasound-guided gallbladder drainage (EUS-GB) is an emerging alternative to choledochoduodenostomy (EUS-CBD) for malignant distal biliary obstruction (MDBO), particularly when conventional access is not feasible.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: We conducted a multicenter, retrospective study of patients undergoing EUS-GB or EUS-CBD for MDBO between January 2015 and October 2024. Primary outcomes were technical and clinical success. Secondary outcomes included procedural time, 6-month reintervention, adverse events (AEs), and all-cause mortality. Propensity score matching (PSM) was used to adjust for baseline differences.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e Eighty-two patients were included (22 EUS-GB, 60 EUS-CBD). Technical success was comparable between groups (95.5% vs. 96.7%). EUS-GB was used as salvage in 50% of cases when EUS-CBD was not feasible, with a 90.9% technical success rate. PSM yielded 21 matched pairs. Clinical success was similar (95.2% EUS-GB vs. 85.7% EUS-CBD, \u003cem\u003ep\u003c/em\u003e=0.61). EUS-CBD had significantly lower 6-month reintervention (4.8% vs. 23.8%, \u003cem\u003ep\u003c/em\u003e=0.004) and stent-related complications (0% vs. 18.9%). Adverse event rates and all-cause mortality were similar. Median follow-up was 116 days (IQR: 51–300). In the EUS-GB group, pre-procedural cystic duct patency predicted clinical success (94.1%).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u003c/strong\u003e EUS-GB is a technically effective and clinically comparable alternative to EUS-CDS for MDBO, with significantly fewer reinterventions and stent-related complications. When cystic duct patency is confirmed on imaging, EUS-GB may be considered as a primary approach or salvage strategy for biliary drainage in MDBO.\u003c/p\u003e","manuscriptTitle":"Endoscopic Choledochoduodenostomy versus Gallbladder Drainage for Malignant Biliary Obstruction: A Propensity Score Matched Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-15 11:11:43","doi":"10.21203/rs.3.rs-7032356/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-08-04T23:28:28+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-07-30T16:04:28+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-07-26T09:43:34+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"208797467445266352395383922658719078074","date":"2025-07-16T23:47:49+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"320383525765334888887554838747084384013","date":"2025-07-15T09:52:01+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"113042332091018041004144400318920195627","date":"2025-07-15T02:31:16+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-07-10T23:14:39+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-07-04T23:34:43+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-07-03T11:27:54+00:00","index":"","fulltext":""},{"type":"submitted","content":"Digestive Diseases and Sciences","date":"2025-07-02T19:54:00+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":"9b6ca170-b083-424c-aab6-e6a8ab721d50","owner":[],"postedDate":"July 15th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-09-29T16:02:10+00:00","versionOfRecord":{"articleIdentity":"rs-7032356","link":"https://doi.org/10.1007/s10620-025-09417-w","journal":{"identity":"digestive-diseases-and-sciences","isVorOnly":false,"title":"Digestive Diseases and Sciences"},"publishedOn":"2025-09-24 15:58:09","publishedOnDateReadable":"September 24th, 2025"},"versionCreatedAt":"2025-07-15 11:11:43","video":"","vorDoi":"10.1007/s10620-025-09417-w","vorDoiUrl":"https://doi.org/10.1007/s10620-025-09417-w","workflowStages":[]},"version":"v1","identity":"rs-7032356","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7032356","identity":"rs-7032356","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}