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Clinical Trials in South Korea / NCT06287112
Recruiting Not applicable

Prevention of Acute Cholecystitis With ETGBD

NCT06287112 · tracked via the Priya Life Science South Korea tracker
Sponsor
Seoul National University Hospital
Phase
Not applicable
Started
2024-06-20
Last updated
2025-02-20

Condition(s) studied

Biliary ObstructionAcute Cholecystitis

Investigational drug(s) / intervention(s)

Endoscopic transpapillary gallbladder drainage (ETGBD)

Endoscopic transpapillary gallbladder drainage (ETGBD): Fully covered self-Expandable metal stent with Endoscopic transpapillary gallbladder drainage (ETGBD) in patient with cystic duct low insertion

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul South Korea Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06287112 on ClinicalTrials.gov ↗ ← All trials in South Korea