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Search / Trial NCT06287112

Prevention of Acute Cholecystitis With ETGBD

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Feb 28, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Malignant Biliary Obstruction Fully Covered Self Expandable Metal Stent Endoscopic Transpapillary Gallbladder Drainage Preventive Effect Acute Cholecystitis

ClinConnect Summary

This clinical trial is studying a new method called endoscopic transpapillary gallbladder drainage (ETGBD) to see if it can help prevent a serious condition known as acute cholecystitis, which is inflammation of the gallbladder. The researchers believe that using a specific type of stent (a small tube that helps keep the duct open) during this procedure may be more effective for patients whose gallbladder ducts connect lower in the bile duct. By comparing the rates of complications and the need for additional procedures, they hope to find out if this approach truly offers benefits.

To be eligible for the trial, participants must be adults aged 19 or older and need to have certain imaging tests confirming the position of their gallbladder ducts. They should also be willing to give informed consent to join the study. However, individuals who have had previous drainage procedures, certain gastrointestinal issues, or other serious conditions like acute cholecystitis or pancreatitis won't be able to participate. If you join the trial, you can expect to undergo some tests and procedures related to your condition, all while contributing to important research that could improve treatment options for others in the future.

Gender

ALL

Eligibility criteria

  • 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

About Seoul National University Hospital

Seoul National University Hospital (SNUH) is a leading medical institution in South Korea, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, SNUH integrates cutting-edge scientific inquiry with patient-centered care, facilitating the development of novel therapies and treatment protocols. The hospital boasts a diverse range of specialized departments and a robust infrastructure for conducting clinical studies, ensuring rigorous adherence to ethical standards and regulatory compliance. By fostering collaboration among multidisciplinary teams, SNUH aims to contribute significantly to global medical advancements and improve patient outcomes.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Woo Hyun Paik, MD., PhD.

Study Director

Seoul National University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported