Prevention of Acute Cholecystitis With ETGBD

NCT06287112 | Recruiting DMC

• 1 other identifier: PAC-ETGBD
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Obstruction; Acute Cholecystitis

Keywords

Malignant biliary obstruction; Fully covered self expandable metal stent; Endoscopic transpapillary gallbladder drainage; Preventive Effect; Acute cholecystitis

Outcome Measures

Primary Outcomes (1)

• Incidence rate of acute cholecystitis

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

  2 months from the date of stent placement

Study Arms (1)

PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD)

EXPERIMENTAL

Device: Endoscopic transpapillary gallbladder drainage (ETGBD)

Interventions

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

PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Woo Hyun Paik, MD., PhD.

  Seoul National University Hospital

  STUDY DIRECTOR

Central Study Contacts

Myeong Hwan Lee, MD.

CONTACT

+82-10-7733-6494; dlaudghks01@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 29, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): March 30, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-02

Locations

KR (1)