PMID- 36537290
OWN - NLM
STAT- MEDLINE
DCOM- 20230811
LR  - 20230829
IS  - 1528-1140 (Electronic)
IS  - 0003-4932 (Print)
IS  - 0003-4932 (Linking)
VI  - 278
IP  - 3
DP  - 2023 Sep 1
TI  - Endoscopic Ultrasound-guided Transluminal Gallbladder Drainage in Patients With 
      Acute Cholecystitis: A Prospective Multicenter Trial.
PG  - e556-e562
LID - 10.1097/SLA.0000000000005784 [doi]
AB  - 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.
CI  - Copyright (c) 2022 The Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Irani, Shayan S
AU  - Irani SS
AD  - Division of Gastroenterology, Virginia Mason Medical Center, Seattle, WA.
FAU - Sharma, Neil R
AU  - Sharma NR
AD  - Division of Interventional Oncology and Surgical Endoscopy (IOSE), Parkview 
      Cancer Institute, Ft. Wayne, IN.
FAU - Storm, Andrew C
AU  - Storm AC
AD  - Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN.
FAU - Shah, Raj J
AU  - Shah RJ
AD  - Division of Gastroenterology and Hepatology, University of Colorado Anschutz 
      Medical Campus, Aurora, CO.
FAU - Chahal, Prabhleen
AU  - Chahal P
AD  - Division of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, 
      Cleveland, OH.
FAU - Willingham, Field F
AU  - Willingham FF
AD  - Division of Digestive Diseases, Department of Medicine, Emory University, 
      Atlanta, GA.
FAU - Swanstrom, Lee
AU  - Swanstrom L
AD  - IHU-Strasbourg, Institute for Image Guided Surgery, Strasbourg, France.
FAU - Baron, Todd H
AU  - Baron TH
AD  - Division of Gastroenterology and Hepatology, Director of Advanced Therapeutic 
      Endoscopy, University of North Carolina at Chapel Hill, Chapel Hill, NC.
FAU - Shlomovitz, Eran
AU  - Shlomovitz E
AD  - Department of Interventional Radiology, University of Toronto, Toronto, ON, 
      Canada.
FAU - Kozarek, Richard A
AU  - Kozarek RA
AD  - Division of Gastroenterology, Virginia Mason Medical Center, Seattle, WA.
FAU - Peetermans, Joyce A
AU  - Peetermans JA
AD  - Endoscopy Division, Boston Scientific Corporation, Marlborough, MA.
FAU - McMullen, Edmund
AU  - McMullen E
AD  - Endoscopy Division, Boston Scientific Corporation, Marlborough, MA.
FAU - Ho, Evelyne
AU  - Ho E
AD  - Endoscopy Division, Boston Scientific Corporation, Marlborough, MA.
FAU - van der Merwe, Schalk W
AU  - van der Merwe SW
AD  - Division of Gastroenterology and Hepatology, UZ Leuven, Leuven, Belgium.
LA  - eng
SI  - ClinicalTrials.gov/NCT03767881
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20221220
PL  - United States
TA  - Ann Surg
JT  - Annals of surgery
JID - 0372354
SB  - IM
MH  - Humans
MH  - *Gallbladder/diagnostic imaging/surgery
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - *Cholecystitis, Acute/diagnostic imaging/surgery
MH  - Endosonography
MH  - Drainage/adverse effects
MH  - Stents
MH  - Ultrasonography, Interventional
PMC - PMC10414151
EDAT- 2022/12/21 06:00
MHDA- 2023/08/11 06:42
PMCR- 2023/08/10
CRDT- 2022/12/20 05:02
PHST- 2023/08/11 06:42 [medline]
PHST- 2022/12/21 06:00 [pubmed]
PHST- 2022/12/20 05:02 [entrez]
PHST- 2023/08/10 00:00 [pmc-release]
AID - 00000658-202309000-00037 [pii]
AID - ANNSURG-D-22-01574 [pii]
AID - 10.1097/SLA.0000000000005784 [doi]
PST - ppublish
SO  - Ann Surg. 2023 Sep 1;278(3):e556-e562. doi: 10.1097/SLA.0000000000005784. Epub 
      2022 Dec 20.