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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Endoscopic Ultrasound-guided Transluminal Gallbladder Drainage in Patients with Acute Cholecystitis: A Prospective Multicenter Trial
Annals of Surgery, Volume 278, No. 3, Year 2023
Notification
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Description
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. © 2023 Lippincott Williams and Wilkins. All rights reserved.
Authors & Co-Authors
Irani, Shayan S.
United States, Seattle
Virginia Mason Medical Center
Baron, Todd Huntley
United States, Chapel Hill
The University of North Carolina at Chapel Hill
Kozarek, Richard A.
United States, Seattle
Virginia Mason Medical Center
Peetermans, Joyce A.
United States, Marlborough
Boston Scientific Corporation
McMullen, Edmund A.
United States, Marlborough
Boston Scientific Corporation
van der Merwe, Schalk Willem
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Statistics
Citations: 6
Authors: 6
Affiliations: 9
Identifiers
Doi:
10.1097/SLA.0000000000005784
ISSN:
00034932
Research Areas
Health System And Policy
Study Design
Cohort Study