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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-28

Study Completion Date

2028-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Continuous suture technique

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

Group Type EXPERIMENTAL

Continous suture technique

Intervention Type PROCEDURE

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

Interrupted suture

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

Group Type ACTIVE_COMPARATOR

Interrupted suture technique

Intervention Type PROCEDURE

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

Interventions

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Continous suture technique

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

Intervention Type PROCEDURE

Interrupted suture technique

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No