Prevention of Acute Cholecystitis With ETGBD

Not Applicable

Recruiting

• Conditions: Acute Cholecystitis; Biliary Obstruction
• Interventions: Device: Endoscopic transpapillary gallbladder drainage (ETGBD)

• Registration Number: NCT06287112
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The goal of this clinical trial is to learn about Efficacy of the ETGBD parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion.

In this study, we hypothesized that endoscopic transpapillary gallbladder drainage (ETGBD) with parallel insertion of a fully covered self-expanding metal stent(FCSEMS) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. And we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-02-29
• Study Start: 2024-06-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20
• Primary Completion: 2027-02-20
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Adults 19 years of age or older
2. Patients requiring endoscopic retrograde cholangiography and drainage for therapeutic purposes.
3. Patients with imaging (CT, Cholangiogram) confirmed confluence of the cystic duct with the distal third of the common bile duct.
4. Patients who have voluntary informed consent to participate in the study.

Exclusion Criteria

• Patients who have undergone percutaneous/surgical bile duct or gallbladder drainage prior to study enrollment.
• Patients with anatomic deformity of the upper gastrointestinal tract after gastric or hepatobiliary surgery
• Patients with concomitant gastric/duodenal obstruction
• Patients with confirmed or suspected cystic duct obstruction on imaging studies
• Patients with acute cholecystitis, acute pancreatitis
• Patients who underwent cholecystectomy
• Patients with a life expectancy of less than 3 months
• Patients who are otherwise unable to undergo endoscopic retrograde cholangiopancreatography

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD)	Endoscopic transpapillary gallbladder drainage (ETGBD)	-

Primary Outcome Measures

Name	Time	Method
Incidence rate of acute cholecystitis	2 months from the date of stent placement	Diagnosis of Acute cholecystitis will be based on the Tokyo Guidelines 2018

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of