🔎 Trials Near Me

Home › NCT07696546

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

Sponsor: Orlando Health, Inc. · Participants: 110 · Started: 2026-07

Contact the study team

Official record on ClinicalTrials.gov — NCT07696546

Locations in the U.S.

FloridaOrlando 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.