Department of General, Transplantation and Liver Surgery UCC MUW
Warsaw, Masovian Voivodeship, 02-097, Poland
Location status: Recruiting
Location contact
Jan Stypułkowski, MD
CONTACT
Krzysztof Dudek, MD, PhD
CONTACT
NCT Number: NCT06533592
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Warsaw, Masovian Voivodeship, 02-097, Poland
Location status: Recruiting
Jan Stypułkowski, MD
CONTACT
Krzysztof Dudek, MD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Duct-to-duct anastomosis will be performed using continuous suture technique for study group
Duct-to-duct anastomosis will be performed using an interrupted suture for control group,
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
Time frame: 90 days post transplantation
Defined as the need for radiologic, endoscopic or operative intervention resulting from increased serum bilirubin concentration
Time frame: 90 days post transplantation
Occurence of complication assessed in Clavien-Dindo scale
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
Time frame: 2 years post transplantation
Time frame: 2 years post transplantation
Time frame: 2 years post transplantation
Evaluated with EORTC QLQ-C30 form
Contact information is provided by the study sponsor or research team.
Jan Stypułkowski, MD
CONTACT
Krzysztof Dudek, MD, PhD
CONTACT
Medical University of Warsaw
Other
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.
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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