Acute Cholecystitis, Biliary Obstruction
Conditions
Keywords
Malignant biliary obstruction, Fully covered self expandable metal stent, Endoscopic transpapillary gallbladder drainage, Preventive Effect, Acute cholecystitis
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.
Interventions
DEVICEEndoscopic transpapillary gallbladder drainage (ETGBD)
Fully covered self-Expandable metal stent with Endoscopic transpapillary gallbladder drainage (ETGBD) in patient with cystic duct low insertion
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of acute cholecystitis | 2 months from the date of stent placement | Diagnosis of Acute cholecystitis will be based on the Tokyo Guidelines 2018 |
Countries
South Korea
Contacts
Primary ContactMyeong Hwan Lee, MD.
Outcome results
None listed