Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT06287112

Prevention of Acute Cholecystitis With ETGBD

Led by Seoul National University Hospital · Updated on 2025-02-20

35

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Prevention of Acute Cholecystitis With ETGBD

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 19 years of age or older
  • Patients requiring endoscopic retrograde cholangiography and drainage for therapeutic purposes
  • Patients with imaging (CT, Cholangiogram) confirmed confluence of the cystic duct with the distal third of the common bile duct
  • Patients who have voluntary informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Patients who have undergone percutaneous or 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 or duodenal obstruction
  • Patients with confirmed or suspected cystic duct obstruction on imaging studies
  • Patients with acute cholecystitis or 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea, 03080

Actively Recruiting

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Research Team

M

Myeong Hwan Lee, MD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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Prevention of Acute Cholecystitis With ETGBD | DecenTrialz