Comparing two surgical techniques for bile duct connection in liver transplantation
A Prospective Randomized Study to Evaluate the Effect of the Type of Conduit-duct Anastomosis Using the Single/continuous Suture Technique on the Postoperative Course in Patients Undergoing Liver Transplantation from a Deceased Donor.
This study is testing two different surgical methods for connecting bile ducts during liver transplants to see which one leads to fewer complications and better recovery for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 284 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Trial ID | NCT06533592 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of two surgical techniques for duct-to-duct anastomosis during liver transplantation: the continuous suture method and the interrupted suture method. A total of 284 patients undergoing elective liver transplantation from deceased donors will be randomized into two groups to assess the risk of bile leakages and other postoperative complications within a 90-day follow-up period. Additionally, long-term biliary complications will be monitored over a two-year observation period. The study focuses on improving postoperative outcomes and quality of life for liver transplant recipients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are undergoing elective liver transplantation from deceased donors.
Not a fit: Patients who are under 18, pregnant, or undergoing living donor liver transplantation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced rates of bile leaks and other complications following liver transplantation, improving patient recovery and quality of life.
How similar studies have performed: While there have been studies on surgical techniques in liver transplantation, this specific comparison of continuous versus interrupted suture methods is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age over 18 * elective liver transplantation * informed consent to participate in the study * recipient bile duct diameter over 3mm * donor bile duct diameter over 3mm Exclusion Criteria: * age below 18 * pregnancy * living donor liver transplantation * split-liver or reduced-size liver transplantation * liver transplantation other than from brain death donor * liver transplantation with hepaticojejunostomy * patients undergoing re-transplantation * multi-organ transplantation * recipient bile duct diameter below 3mm * donor bile duct diameter below 3mm
Where this trial is running
Warsaw, Masovian Voivodeship
- Department of General, Transplantation and Liver Surgery UCC MUW — Warsaw, Masovian Voivodeship, Poland (Recruiting)
Study contacts
- Study coordinator: Krzysztof Dudek, MD, PhD
- Email: krzysztof.dudek@wum.edu.pl
- Phone: +48 225992542
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.