NCT07696546
Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage
Recruiting
NAAges 18+InterventionalTreatmentOrlando Health, Inc.Investigator-initiated
~110 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Percutaneous cholecystostomyEUS-guided gallbladder drainage
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events
Measured over 36 months
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Ji Young Bang, MD MPH · PRINCIPAL_INVESTIGATOR · Orlando Health, Digestive Health Institute
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events36 months
A composite endpoint of 1) procedure-related adverse events, 2) reintervention for disease recurrence or procedure-related adverse events, and/or 3) readmission due to underlying disease or procedure-related adverse events, from index procedure to 36 months post-index intervention.