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

NCT06533592 | Recruiting DMC

• 1 other identifier: 2023/ABM/01/00017
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 1

Brief Summary

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

Liver Transplant; Complications; Bile Duct; Stricture, Postoperative; Bile Leak; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Critical biliary stricture

  90 days post transplantation

• Other surgical complications

  90 days post transplantation

• Long-term biliary complications

  2 years post transplantation

• Overall survival

  2 years post transplantation

• Overall graft survival

  2 years post transplantation

Study Arms (2)

Continuous suture technique

EXPERIMENTAL

Biliary duct-to-duct anastomosis performed with continous suture technique

Procedure: Continous suture technique

Interrupted suture

ACTIVE COMPARATOR

Biliary duct-to-duct anastomosis performed with interrupted suture technique - control group

Procedure: Interrupted suture technique

Interventions

Continous suture technique PROCEDURE

Duct-to-duct anastomosis will be performed using continuous suture technique for study group

Continuous suture technique

Interrupted suture technique PROCEDURE

Duct-to-duct anastomosis will be performed using an interrupted suture for control group,

Interrupted suture

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of General, Transplantation and Liver Surgery UCC MUW

Warsaw, Masovian Voivodeship, 02-097, Poland

RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Krzysztof Dudek, MD, PhD

CONTACT

+48 225992542; krzysztof.dudek@wum.edu.pl

Jan Stypułkowski, MD

CONTACT

+48 225992459; jan.stypulkowski@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: August 1, 2024
• Study Start: September 28, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 24, 2024

Record last verified: 2024-06

Locations

PL (1)