Evaluating external biliary drainage in living donor liver transplantation
A Prospective Randomized Controlled Trial for Application of External Biliary Drainage in Living Donor Liver Transplantation
This study is testing whether using external biliary drainage during living donor liver transplants can help reduce complications compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 19 Years to 79 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT04622540 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the incidence of biliary complications following living donor liver transplantation (LDLT) by comparing two groups: one receiving external biliary drainage (EBD) and the other undergoing conventional duct-to-duct anastomosis without EBD. Patients aged 18 and older who are eligible for LDLT will be randomly assigned to either group in a 1:1 ratio. The primary outcome will measure the rate of biliary complications one year post-transplant. This prospective approach seeks to determine if EBD can effectively reduce complications associated with LDLT.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are undergoing living donor liver transplantation and can commit to a 3-year follow-up.
Not a fit: Patients requiring hepaticojejunostomy, those undergoing re-transplantation, or emergency transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of biliary complications in patients undergoing living donor liver transplantation.
How similar studies have performed: While there have been various approaches to managing biliary complications in liver transplantation, the specific application of external biliary drainage in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Living donor liver transplantation * Adult patient (\>=18 years old) * Patients who are available for at least 3 year follow-up after LDLT Exclusion Criteria: * Patients requring hepaticojejunostomy due to anatomical factor or underlying disease * Re-transplantation * Multiorgan transplantation * Emergency transplantation
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Su young Hong, MD
- Email: sypurple@gmail.com
- Phone: +82-2-2072-2326
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.