Preventing acute cholecystitis using endoscopic techniques
Efficacy of ETGBD Parallel Insertion With Fully Covered Self-expandable Metal Stent for Preventing Acute Cholecystitis in Patients With Low Cystic Duct Insertion
NA · Seoul National University Hospital · NCT06287112
This study is testing if a new endoscopic technique can help prevent acute cholecystitis in patients with certain conditions better than standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06287112 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy of endoscopic transpapillary gallbladder drainage (ETGBD) combined with the insertion of a fully covered self-expanding metal stent in preventing acute cholecystitis in patients with specific anatomical conditions. The study hypothesizes that this approach will reduce the frequency and severity of complications associated with biliary obstruction. Participants will be monitored for the occurrence of cholecystitis and the need for additional invasive procedures. The trial will compare outcomes in patients receiving this intervention against standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with confirmed biliary obstruction and specific anatomical conditions.
Not a fit: Patients with prior gallbladder drainage procedures or those with acute cholecystitis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute cholecystitis in at-risk patients.
How similar studies have performed: While similar approaches have been explored, this specific combination of ETGBD and fully covered stents is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Study coordinator: Myeong Hwan Lee, MD.
- Email: dlaudghks01@snu.ac.kr
- Phone: +82-10-7733-6494
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Biliary Obstruction, Acute Cholecystitis, Malignant biliary obstruction, Fully covered self expandable metal stent, Endoscopic transpapillary gallbladder drainage, Preventive Effect, Acute cholecystitis