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NCT Number: NCT06287112

Prevention of Acute Cholecystitis With ETGBD

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.

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Key information

Conditions

Biliary Obstruction Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

Location status: Recruiting

Location contact

Woo Hyun Paik, MD, PhD

CONTACT

[email protected]

+82220722228

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Endoscopic transpapillary gallbladder drainage (ETGBD)

Device

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

Primary outcomes

  1. Incidence rate of acute cholecystitis

    Time frame: 2 months from the date of stent placement

    Diagnosis of Acute cholecystitis will be based on the Tokyo Guidelines 2018

Study contacts

Contact information is provided by the study sponsor or research team.

Myeong Hwan Lee, MD.

CONTACT

[email protected]

+82-10-7733-6494

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 29, 2024
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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