Recruiting

Percutaneous Cholecystostomy vs. Endoscopic Ultrasound-guided Drainage

Sponsor:

Orlando Health, Inc.

Code:

NCT07696546

Conditions

Acute Cholecystitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Percutaneous cholecystostomy

EUS-guided gallbladder drainage

Study Details

Brief 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

Study ID

NCT07696546

Start date

Jul, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Jun, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Percutaneous cholecystostomy

Percutaneous cholecystostomy tube placement by interventional radiology

EUS-guided gallbladder drainage

EUS-guided gallbladder drainage using metal stent

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 and Locations

Central contacts

Ji Young Bang, MD MPH

321-842-2273jiyoung.bang@orlandohealth.com

Barbara J Broome

321-841-4356barbara.broome@orlandohealth.com

Locations

Orlando Health Digestive Health Institute

Recruiting

Orlando, Florida, United States, 32806

Contacts

Ji Young Bang, MD MPH

321-842-2273jiyoung.bang@orlandohealth.com

Barbara J Broome

321-841-4356barbara.broome@orlandohealth.com

More Information

Sponsor

Orlando Health, Inc.

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Keywords

  • EUS-guided gallbladder drainage
  • percutaneous cholecystostomy
  • Acute calculous cholecystitis
  • Endoscopic ultrasound
  • Interventional radiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orlando Health, Inc. on 2026-07-10.