RecruitingNot ApplicableNCT07696546

Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage

Percutaneous or Endoscopic Gallbladder Drainage: The PEG Trial

Sponsor

Orlando Health, Inc.

Enrollment

110 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Acute Cholecystitis

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria10

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