Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 11:29 AM
Study NCT ID:
NCT03673033
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2018-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biliary Complications in Live Donor Liver Transplantation
Sponsor:
Inonu University
Organization:
Study Overview
Official Title:
Can the Effects of Cold and Hot Ischemia Time on Biliary Complications in Live Donor Liver Transplantation Be Classified?
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study was designed as a prospective cohort study. The effects of hot and cold ischemic times during live donor liver transplantation on postoperative 1-3 and 6 month follow up biliary complications will be investigated.
Detailed Description:
The invastigators will record the age, gender, weight, diagnosis, presence of hcc (hepatocellular carcinoma), whether transcatheter embolization (transarterial radiolabelization) is performed, meld score, age of donor, gender, graft hepatic artery diameter, bile duct diameter and number before surgery.
During the operation,
The duration of ischemia will be evaluated as three stages.
During the first stage donor hepatectomy, the time from the interruption of the hepatic artery to the first administration of the solution to the bile ducts on the back table will be recorded and recorded as the first ischemia time.
The time from the administration of the solution to the biliary system on the stage 2 back-to-back table until the cold anastomosis is performed will be recorded as the duration of cold ischemia.
The time from the third graft to receipt of the graft to the end of the hepatic artery anastomosis will be recorded as the second ischemia time.
The duration of operation, whether or not pringle maneuvers were performed, hepatic artery thrombus, graft bile number, number of bile anastomoses, lowest biliary tract diameter and hepatic artery diameter
After the surgery,
The use of immunosuppression (Tacrolimus, certican or combined use) will be recorded.
During the follow-up period of 1,3,6 months, complaints of the patients, laboratory values and imaging methods as well as whether or not there is biliary complication (leakage, stenosis) will be recorded.
If the complication develops during follow-up, the procedure (follow-up, ercp, ptk, surgery) will be recorded.
Since the study is observational, normal treatment will not be involved.
Participants will not be included in the study in the presence of hepaticojejunostomy patients, cadaveric transplant patients, pediatric transplant patients, Cmv infection, hepatic artery thrombosis, portal thrombosis, acute rejection in the first operation.
Participants with live donor liver transplant patients, multiple gallbladder anastomoses or single bile duct multiple anastomoses will be included.
When the power analysis for the study was taken as α = 0.05 and 1-β (power) = 0,80, it was calculated that at least 99 patients should be taken to have a difference of 38% in the rates of biliary complication in cold ischemia.
The demographic and all findings of the disease will be collected at excell and at the end of the study all the findings will be statistically evaluated and the results will be evaluated.
During the operation,
The duration of ischemia will be evaluated as three stages.
During the first stage donor hepatectomy, the time from the interruption of the hepatic artery to the first administration of the solution to the bile ducts on the back table will be recorded and recorded as the first ischemia time.
The time from the administration of the solution to the biliary system on the stage 2 back-to-back table until the cold anastomosis is performed will be recorded as the duration of cold ischemia.
The time from the third graft to receipt of the graft to the end of the hepatic artery anastomosis will be recorded as the second ischemia time.
The duration of operation, whether or not pringle maneuvers were performed, hepatic artery thrombus, graft bile number, number of bile anastomoses, lowest biliary tract diameter and hepatic artery diameter
After the surgery,
The use of immunosuppression (Tacrolimus, certican or combined use) will be recorded.
During the follow-up period of 1,3,6 months, complaints of the patients, laboratory values and imaging methods as well as whether or not there is biliary complication (leakage, stenosis) will be recorded.
If the complication develops during follow-up, the procedure (follow-up, ercp, ptk, surgery) will be recorded.
Since the study is observational, normal treatment will not be involved.
Participants will not be included in the study in the presence of hepaticojejunostomy patients, cadaveric transplant patients, pediatric transplant patients, Cmv infection, hepatic artery thrombosis, portal thrombosis, acute rejection in the first operation.
Participants with live donor liver transplant patients, multiple gallbladder anastomoses or single bile duct multiple anastomoses will be included.
When the power analysis for the study was taken as α = 0.05 and 1-β (power) = 0,80, it was calculated that at least 99 patients should be taken to have a difference of 38% in the rates of biliary complication in cold ischemia.
The demographic and all findings of the disease will be collected at excell and at the end of the study all the findings will be statistically evaluated and the results will be evaluated.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: