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Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage

NCT07696546 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-07-10

No results posted yet for this study

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.

Conditions

  • Acute Cholecystitis

Interventions

PROCEDURE

Percutaneous cholecystostomy

Percutaneous cholecystostomy tube placement by interventional radiology

PROCEDURE

EUS-guided gallbladder drainage

EUS-guided gallbladder drainage using metal stent

Sponsors & Collaborators

  • Orlando Health, Inc.

    lead OTHER

Principal Investigators

  • Ji Young Bang, MD MPH · Orlando Health, Digestive Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2032-06-30
Completion
2032-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07696546 on ClinicalTrials.gov