Prevention of Acute Cholecystitis With ETGBD

NCT ID: NCT06287112

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2027-03-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PAC-ETGBD (Prevention of Acute Cholecystitis with ETGBD)

Group Type: EXPERIMENTAL

Endoscopic transpapillary gallbladder drainage (ETGBD)

Intervention Type: DEVICE

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

Interventions

Endoscopic transpapillary gallbladder drainage (ETGBD)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Woo Hyun Paik

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Woo Hyun Paik, MD., PhD.

Role: STUDY_DIRECTOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Myeong Hwan Lee, MD.

Role: CONTACT

dlaudghks01@snu.ac.kr

+82-10-7733-6494

Facility Contacts

Woo Hyun Paik, MD, PhD

Role: primary

iatrus@snu.ac.kr

+82220722228

Other Identifiers

PAC-ETGBD

Identifier Type: -

Identifier Source: org_study_id