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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Liver Transplant; Complications; Bile Leak; Bile Duct; Stricture, Postoperative
• Intervention / Treatment: Procedure: Continous suture technique; Procedure: Interrupted suture technique

• Study Type: Interventional
• Enrollment (Estimated): 284
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Krzysztof Dudek, MD, PhD; Phone Number: +48 225992542; Email: krzysztof.dudek@wum.edu.pl
• Study Contact Backup: Name: Jan Stypułkowski, MD; Phone Number: +48 225992459; Email: jan.stypulkowski@wum.edu.pl

Study Locations

• Poland
  • Masovian voivodeship
    • Warsaw, Masovian voivodeship, Poland, 02-097
      • Recruiting
      • Department of General, Transplantation and Liver Surgery UCC MUW
      • Contact: Krzysztof Dudek, MD, PhD; Phone Number: +48 225992542; Email: krzysztof.dudek@wum.edu.pl
      • Contact: Jan Stypułkowski, MD; Phone Number: +48 225992459; Email: jan.stypulkowski@wum.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous suture technique; Biliary duct-to-duct anastomosis performed with continous suture technique	Procedure: Continous suture technique; Duct-to-duct anastomosis will be performed using continuous suture technique for study group
Active Comparator: Interrupted suture; Biliary duct-to-duct anastomosis performed with interrupted suture technique - control group	Procedure: Interrupted suture technique; Duct-to-duct anastomosis will be performed using an interrupted suture for control group,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bile leakage	Defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration or as the need for radiologic or operative intervention resulting from biliary collections or bile peritonitis up to 90 days post transplantation	90 days post transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		2 years post transplantation
Critical biliary stricture	Defined as the need for radiologic, endoscopic or operative intervention resulting from increased serum bilirubin concentration	90 days post transplantation
Other surgical complications	Occurence of complication assessed in Clavien-Dindo scale	90 days post transplantation
Long-term biliary complications	Defined as occurence of biliary leak, biliary stricture, peripheral cholangiopathy, recurrent cholangitis between 90 days and 2 years post transplantation	2 years post transplantation
Overall graft survival		2 years post transplantation
Impact of the occurrence of a biliary complication on the quality of life of patients	Evaluated with EORTC QLQ-C30 form	2 years post transplantation

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: July 9, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2023/ABM/01/00017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No