Prevention of Acute Cholecystitis With ETGBD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic transpapillary gallbladder drainage (ETGBD).
- Who it may be relevant to
- Registry conditions: Biliary Obstruction, Acute Cholecystitis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion
Overview
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.
Interventions
- Device Endoscopic transpapillary gallbladder drainage (ETGBD)
Fully covered self-Expandable metal stent with Endoscopic transpapillary gallbladder drainage (ETGBD) in patient with cystic duct low insertion
Primary outcome measures
- Incidence rate of acute cholecystitis [Time frame: 2 months from the date of stent placement]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06287112 · PAC-ETGBD