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

Not Applicable

Recruiting

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

• Registration Number: NCT06533592
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-08-01
• Study Start: 2024-09-28
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-24
• Primary Completion: 2026-11-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 284

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bile leakage	90 days post transplantation	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of General, Transplantation and Liver Surgery UCC MUW; 🇵🇱 Warsaw, Masovian voivodeship, Poland