NCT07696546

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
77mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Jul 2026Dec 2032

Study Start

First participant enrolled

July 1, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2032

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

5.9 years

First QC Date

July 6, 2026

Last Update Submit

July 6, 2026

Conditions

Acute Cholecystitis

Keywords

EUS-guided gallbladder drainagepercutaneous cholecystostomyAcute calculous cholecystitisEndoscopic ultrasoundInterventional radiology

Outcome Measures

Primary Outcomes (1)

  • 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

    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.

    36 months

Secondary Outcomes (20)

  • Mortality

    30 days

  • Procedure-related adverse events

    36 months

  • Disease-related adverse events

    36 months

  • New onset single and multiple organ failure.

    36 months

  • New onset systemic dysfunction.

    36 months

  • +15 more secondary outcomes

Study Arms (2)

Percutaneous cholecystostomy

ACTIVE COMPARATOR

Patients with acute calculous cholecystitis who are never-surgery candidates undergoing percutaneous cholecystostomy tube placement

Procedure: Percutaneous cholecystostomy

EUS-guided gallbladder drainage

ACTIVE COMPARATOR

Patients with acute calculous cholecystitis who are never-surgery candidates, undergoing EUS-guided gallbladder drainage

Procedure: EUS-guided gallbladder drainage

Interventions

Percutaneous cholecystostomyPROCEDURE

Percutaneous cholecystostomy tube placement by interventional radiology

Percutaneous cholecystostomy
EUS-guided gallbladder drainagePROCEDURE

EUS-guided gallbladder drainage using metal stent

EUS-guided gallbladder drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orlando Health Digestive Health Institute

Orlando, Florida, 32806, United States

RECRUITING

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Ji Young Bang, MD MPH

    Orlando Health, Digestive Health Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ji Young Bang, MD MPH

CONTACT

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

Barbara J Broome

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2026

First Posted

July 10, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

June 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)