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Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage
Recruiting
Percutaneous or Endoscopic Gallbladder Drainage: The PEG Trial
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Patients with suspected or confirmed acute calculous cholecystitis, diagnosed per Tokyo guidelines * Age ≥ 18 years * Patients due to severe comorbidity who are deemed to be never-surgery candidates by the multidisciplinary team or patients who refuse to undergo surgery. * Patients can undergo EUS-guided drainage and percutaneous cholecystostomy tube placement. * Written informed consent by the patient or guardian who can understand the nature and possible consequences of participation in the study. Exclusion Criteria: * Pregnancy * Patients who are potential candidates for future cholecystectomy. * Patients unwilling to undergo follow-up assessments. * Patients with suspected gangrene or perforation of the gallbladder * Patients are diagnosed with concomitant liver abscess or necrotizing pancreatitis. * Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum. * Indwelling percutaneous cholecystostomy tube. * Refractory/persistently significant ascites despite paracentesis. * Distance between the gallbladder and gastric/duodenal wall that cannot be bridged by the metal stent. * Abnormal coagulation parameters that cannot be correct: INR \> 1.7 and/or platelets \< 50.000/mm3
About the study
This is a randomized trial of patients with acute calculous cholecystitis who are never-surgery candidates. Patients will be randomized to one of two treatment groups, percutaneous cholecystostomy or endoscopic ultrasound-guided drainage. The aim of the study is to compare between these two treatment methods, the treatment outcomes and quality of life over a follow-up duration of 36 months.
What is being tested
- Percutaneous cholecystostomy (procedure)
- EUS-guided gallbladder drainage (procedure)
Sponsor: Orlando Health, Inc. · Participants: 110 · Started: 2026-07
Contact the study team
- Ji Young Bang, MD MPH · Phone: 321-842-2273
- Barbara J Broome · Phone: 321-841-4356
Official record on ClinicalTrials.gov — NCT07696546
Locations in the U.S.
| Florida | Orlando Health Digestive Health Institute, Orlando |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.