Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT06533592

The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation

Led by Medical University of Warsaw · Updated on 2024-10-24

284

Participants Needed

1

Research Sites

204 weeks

Total Duration

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AI-Summary

What this Trial Is About

The main objective of the trial is to compare the effect of two end-to-end duct-to-duct anastomosis surgical techniques using the continuous suture method versus interrupted method (control group) on reducing the risk of bile leakages in the 90-day follow-up period after liver transplantation and other postoperative complications resulting from them i.e.: the occurrence of a critical stenosis in the duct-to-duct anastomosis within 90 days. In addition, as part of the research experiment, long-term biliary complications will be assessed, i.e. occurring over a period of more than 90 days (a 2-year observation period of patients was assumed). As part of the trial 284 patients qualified for the procedure of liver transplantation from a deceased donor will be included, in whom end-to-end anastomosis of the bile ducts will be performed. After entering the study, patients will be randomized to one of the groups. In the group of 142 patients, duct-to-duct anastomosis will be performed using an interrupted suture (control group), and the remaining patients will be performed using the continuous suture technique. The analysis will also include surgical complications, complications related to early and late graft function, retransplantation and overall survival. Additionally the analyses an analysis of the impact of the occurrence of a biliary complication on the quality of life of patients after liver transplantation will be performed on the basis of the EORTC QLQ-C30 forms. The period of observation of the patient after the procedure is planned for 24 months.

CONDITIONS

Official Title

The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Elective liver transplantation
  • Informed consent to participate in the study
  • Recipient bile duct diameter over 3 mm
  • Donor bile duct diameter over 3 mm
Not Eligible

You will not qualify if you...

  • Age below 18 years
  • 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 3 mm
  • Donor bile duct diameter below 3 mm

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of General, Transplantation and Liver Surgery UCC MUW

Warsaw, Masovian Voivodeship, Poland, 02-097

Actively Recruiting

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Research Team

K

Krzysztof Dudek, MD, PhD

CONTACT

J

Jan Stypułkowski, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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