Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533592
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Study to Evaluate the Effect of the Type of Conduit-duct Anastomosis Using the Singlecontinuous Suture Technique on the Postoperative Course in Patients Undergoing Liver Transplantation from a Deceased Donor
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 ie 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None