Randomized Trial of Percutaneous vs. Endoscopic Gallbladder Drainage

Conditions

• Acute Cholecystitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Percutaneous cholecystostomy — PROCEDURE
  Percutaneous cholecystostomy tube placement by interventional radiology
• EUS-guided gallbladder drainage — PROCEDURE
  EUS-guided gallbladder drainage using metal stent

Study Details

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 Dates

First listed

Jul 10, 2026

Start date

Jul 31, 2026

Status verified

Jul 2026

Primary completion

Jun 30, 2032

Completion

Dec 31, 2032

Study Design

Enrollment

110 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Percutaneous cholecystostomy
  Patients with acute calculous cholecystitis who are never-surgery candidates undergoing percutaneous cholecystostomy tube placement
• Active Comparator: EUS-guided gallbladder drainage
  Patients with acute calculous cholecystitis who are never-surgery candidates, undergoing EUS-guided gallbladder drainage

Primary Outcome Measure

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 [ Time Frame: 36 months ]

Central Contacts

• Ji Young Bang, MD MPH
  321-842-2273
  [email protected]
• Barbara J Broome
  321-841-4356
  [email protected]

Locations (1)

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