Percutaneous vs. Endoscopic Gallbladder Drainage for those who aren’t surgery candidates

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with acute calculous cholecystitis who are too frail for surgery are randomly assigned to receive either a percutaneous cholecystostomy or an endoscopic ultrasound-guided gallbladder drainage. The study compares treatment outcomes and quality of life over 36 months. The goal is to determine which approach provides better symptom relief, fewer complications, and improved well-being in this high-risk group. Procedures are performed by specialists in interventional radiology and endoscopy, with follow-up assessments to monitor recovery and longer-term effects.

Why it matters

Who can join: the full rules

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

Where it's running

• Orlando Health Digestive Health Institute
  Orlando, Florida, United States Recruiting

Study contacts

• Principal investigator: Ji Young Bang, MD MPH — Orlando Health, Digestive Health Institute
• Study coordinator: Ji Young Bang, MD MPH
• Email: jiyoung.bang@orlandohealth.com
• Phone: 321-842-2273

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Preventing acute cholecystitis using endoscopic techniques

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.