Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage
Recruiting now · Not applicable
Conditions studied: Acute Cholecystitis
In brief
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.
Key facts
- Study ID
- NCT07696546
- Run by
- Orlando Health, Inc.
- People needed
- 110
- Starts
- 2026-07-01
- Expected to finish
- 2032-12-01
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Orlando Health Digestive Health Institute — Orlando, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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