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NCT Number: NCT06533592

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continous suture technique

Procedure

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

Interrupted suture technique

Procedure

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

Primary outcomes

  1. Bile leakage

    Time frame: 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 outcomes

  1. Critical biliary stricture

    Time frame: 90 days post transplantation

    Defined as the need for radiologic, endoscopic or operative intervention resulting from increased serum bilirubin concentration

  2. Other surgical complications

    Time frame: 90 days post transplantation

    Occurence of complication assessed in Clavien-Dindo scale

  3. Long-term biliary complications

    Time frame: 2 years post transplantation

    Defined as occurence of biliary leak, biliary stricture, peripheral cholangiopathy, recurrent cholangitis between 90 days and 2 years post transplantation

  4. Overall survival

    Time frame: 2 years post transplantation

  5. Overall graft survival

    Time frame: 2 years post transplantation

  6. Impact of the occurrence of a biliary complication on the quality of life of patients

    Time frame: 2 years post transplantation

    Evaluated with EORTC QLQ-C30 form

Study contacts

Contact information is provided by the study sponsor or research team.

Jan Stypułkowski, MD

CONTACT

[email protected]

+48 225992459

Krzysztof Dudek, MD, PhD

CONTACT

[email protected]

+48 225992542

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Aug 1, 2024
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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