Evaluating external biliary drainage in living donor liver transplantation
Official title: A Prospective Randomized Controlled Trial for Application of External Biliary Drainage in Living Donor Liver Transplantation
Run by Seoul National University Hospital · NCT04622540 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 79 Years |
| Sex | All |
| Enrollment | 124 (estimated) |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | December 9, 2020 |
| Main results expected | November 2024 |
| Study ends | November 2026 |
| Registry record updated | May 12, 2022 |
| Trial ID | NCT04622540 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients requiring hepaticojejunostomy, those undergoing re-transplantation, or emergency transplantation will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.