Actively Recruiting
Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion
Led by Seoul National University Hospital · Updated on 2025-02-20
35
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a procedure called endoscopic transpapillary gallbladder drainage (ETGBD) using a fully covered self-expandable metal stent (FCSEMS) to prevent acute cholecystitis in patients whose cystic duct joins the lower part of the common bile duct. The trial aims to compare how well this treatment prevents complications like cholecystitis by measuring the frequency, severity, and need for additional invasive procedures. The study involves placing the FCSEMS alongside the ETGBD through an endoscopic biliary drainage tunnel in patients with low cystic duct insertion. This approach is hypothesized to better prevent cholecystitis compared to other methods. Participants will receive this device-based treatment during the study period. Participants will be monitored for two months after stent placement to observe the incidence rate of acute cholecystitis. The study will gather information on complications and the need for further invasive procedures. The total duration of participation includes this follow-up period to assess treatment outcomes and safety under clinical observation.
CONDITIONS
Brief Title
Prevention of Acute Cholecystitis With ETGBD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 19 years of age or older
- Patients needing endoscopic retrograde cholangiography and drainage for treatment
- Imaging shows cystic duct joins the distal third of the common bile duct
- Patients who have voluntarily agreed to participate
You will not qualify if you...
- Previous percutaneous or surgical bile duct or gallbladder drainage
- Anatomical deformity of upper gastrointestinal tract after gastric or hepatobiliary surgery
- Gastric or duodenal obstruction
- Confirmed or suspected cystic duct obstruction
- Current acute cholecystitis or acute pancreatitis
- Prior cholecystectomy
- Life expectancy less than 3 months
- Unable to undergo endoscopic retrograde cholangiopancreatography procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo placement of a fully covered self-expandable metal stent with endoscopic transpapillary gallbladder drainage (ETGBD).
1 visit (in-person)
Duration - 2 months
Participants are monitored for the incidence of acute cholecystitis following stent placement.
Follow-up visits over 2 months
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
Research Team
M
Myeong Hwan Lee, MD.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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