Stent misdeployment and factors associated with failure in EUS-guided choledochoduodenostomy: an analysis of the combined datasets from the ELEMENT and DRA-MBO trials.

Background: Stent misdeployment (SMD) is a feared technical challenge of EUS-guided choledochoduodenostomy using a lumen apposing stent (EUS-CDS) that has been poorly characterized. We aim to ascertain the rate of SMD in EUS-CDS for malignant distal biliary obstruction (MDBO) and describe its outcomes while identifying variables associated with its occurrence. In addition, we aim to propose a de novo SMD classification.
Method: A post hoc analysis of two RCTs comparing EUS-CDS vs. endoscopic retrograde cholangiopancreatography in MDBO. The main endpoint was the rate of SMD classified as misdeployment of the distal flange (type I), proximal flange (type II), contralateral bile duct wall injury (type III), or double mucosal puncture (type IV). A multivariable analysis was performed to identify variables associated with the odds of SMD and/or technical failure and clinical failure or stent dysfunction.
Results: 152 patients were included with a technical success of 93.4%. SMDs occurred in 11 (7.2%) patients (95% CI, 3.1%-11.4%): 8 type I, 1 type II, and 2 type III. Endoscopic salvage was successful in 81.8%. SMDs led to an adverse event (AE) in 4 cases (2 mild and 2 moderate) with an overall AE rate of 2.6% (95% CI, 0.7%-6.6%). On multivariable analysis, an extrahepatic bile duct diameter of ≤ 15 mm was associated with increase odds of SMD and/or technical failure.
Conclusion: SMD is relatively common in EUS-CDS and is associated with an extra-hepatic bile duct diameter measuring ≤ 15 mm. The majority of SMDs can be rescued endoscopically with low risk for AE.
Competing Interests: Yen-I Chen is a consultant for Boston Scientific, has received research funding from Boston Scientific and is the co-founder of Chess Medical Inc. Anand Sahai is a consultant Boston Scientific and Pentax. Bertrand Napoleon has received honorarium for proctoring endoscopy training from Maunea Kea, Boston Scientific, Olympus, and Taewoong Medical. Rastislav Kunda is a consultant for Boston Scientific, Olympus, M.I.Tech, Omega Medical Imaging, Q3 Medical-AMG International and EndoGastricSolutions. Nauzer Forbes is a consultant and speaker for Boston Scientific and Pentax Medical, a speaker for AstraZeneca, and has received research funding from Pentax Medical. Anthony Yuen Bun Teoh is a consultant for Boston Scientific, Cook, Taewoong, Microtech, and MI Tech Medical Corporations. All other authors have no relevant conflict of interest.
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