• Annals of surgery · Sep 2023

    Multicenter Study

    EUS-guided Transluminal Gallbladder Drainage in Patients with Acute Cholecystitis: A Prospective Multicenter Trial.

    • Shayan S Irani, Neil R Sharma, Andrew C Storm, Raj J Shah, Prabhleen Chahal, Field F Willingham, Lee Swanstrom, Todd H Baron, Eran Shlomovitz, Richard A Kozarek, Joyce A Peetermans, Edmund McMullen, Evelyne Ho, and Schalk W van der Merwe.
    • Division of Gastroenterology, Virginia Mason Medical Center, Seattle, WA.
    • Ann. Surg. 2023 Sep 1; 278 (3): e556e562e556-e562.

    ObjectiveTo evaluate the safety and efficacy of endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS).BackgroundFor patients with acute cholecystitis who are poor surgical candidates, EUS-GBD using a LAMS is an important treatment alternative to percutaneous gallbladder drainage.MethodsWe 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).ResultsTechnical 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.ConclusionsFor 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.Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

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