Endoscopic Ultrasound-guided Transluminal Gallbladder Drainage in Patients With Acute Cholecystitis: A Prospective Multicenter Trial

• Type of Material: Article
• Authors: Shayan S. Irani, Virginia Mason Medical Center; Neil R. Sharma, Parkview Cancer Institute; Andrew C. Storm, Mayo Clinic; Raj J. Shah, University of Colorado; Prabhleen Chahal, Cleveland Clinic; Field Willingham, Emory University; Lee Swanstrom, Institute for Image Guided Surgery; Todd H. Baron, University of North Carolina; Eran Shlomovitz, University of Toronto; Richard A. Kozarek, Virginia Mason Medical Center; Joyce A. Peetermans, Boston Scientific Corporation; Edmund McMullen, Boston Scientific Corporation; Evelyne Ho, Boston Scientific Corporation; Schalk W. van der Merwe, UZ Leuven
• Language: English
• Date: 2023-09-01
• Publisher: LIPPINCOTT WILLIAMS & WILKINS
• Publication Version: Final Published Version
• Copyright Statement: © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1097/SLA.0000000000005784
• Title of Journal or Parent Work: ANNALS OF SURGERY
• Volume: 278
• Issue: 3
• Start Page: E556
• End Page: E562
• Grant/Funding Information: Grant supported by Boston Scientific Corporation.
• Keywords: metal stents; MANAGEMENT; clinical study; Life Sciences & Biomedicine; TIME; CHOLANGIOSCOPY; PERCUTANEOUS CHOLECYSTOSTOMY; Surgery; Science & Technology; gallbladder; APPOSING METAL STENT; drainage; acute cholecystitis
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Radiology

Abstract

Objective: To evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS). Background: For patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage. Methods: We conducted a regulatory-compliant, prospective multicenter trial at 7 tertiary referral centers in the United States of America and Belgium. Thirty consecutive patients with mild or moderate acute cholecystitis who were not candidates for cholecystectomy were enrolled between September 2019 and August 2021. Eligible patients had a LAMS placed transmurally with 30 to 60-day indwell if removal was clinically indicated, and 30-day follow-up post-LAMS removal. Endpoints included days until acute cholecystitis resolution, reintervention rate, acute cholecystitis recurrence rate, and procedure-related adverse events (AEs). Results: Technical success was 93.3% (28/30) for LAMS placement and 100% for LAMS removal in 19 patients for whom removal was attempted. Five (16.7%) patients required reintervention. Mean time to acute cholecystitis resolution was 1.6±1.5 days. Acute cholecystitis symptoms recurred in 10.0% (3/30) after LAMS removal. Five (16.7%) patients died from unrelated causes. Procedure-related AEs were reported to the FDA in 30.0% (9/30) of patients, including one fatal event 21 days after LAMS removal; however, no AEs were causally related to the LAMS. Conclusions: For selected patients with acute cholecystitis who are at elevated surgical risk, EUS-GBD with LAMS is an alternative to percutaneous gallbladder drainage. It has high technical and clinical success, with low recurrence and an acceptable AE rate. Clinicaltrials.gov, Number: NCT03767881.