Biliary Complications in Live Donor Liver Transplantation

Can the Effects of Cold and Hot Ischemia Time on Biliary Complications in Live Donor Liver Transplantation Be Classified?

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.

Study Overview

• Status: Completed
• Conditions: Bile Leak; Biliary Stricture; Bile Duct Injury; Bile Duct Stenosi
• Intervention / Treatment: Procedure: liver transplantation

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.

• Study Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44090
    • Cihan Gökler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients with live donor liver transplant for any reason

Description

Inclusion Criteria:

Live donor liver transplantation Emergency Live donor liver transplantation Multiple or single bile duct anastomosis in liver transplantation

Exclusion Criteria:

Hepaticojejunostomy Cadaveric liver transplantation Pediatric liver transplantation Cmv infection presence Hepatic arterial thrombus Porta thrombus Acute rejection

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
development of biliary complication in the first month after liver transplantation	biliary complication at the first month after transplantation and whether this complication is interfered with or not will be evaluated.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
development of biliary complication in the three months after liver transplantation	biliary complication at the third month after transplantation and whether this complication is interfered with or not will be evaluated.	3 months
development of biliary complication in the six month after liver transplantation	biliary complication at the sixth month after transplantation and whether this complication is interfered with or not will be evaluated.	6 months

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 10, 2018
• Primary Completion (ACTUAL): July 30, 2019
• Study Completion (ACTUAL): August 3, 2019

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (ACTUAL): September 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2019
• Last Update Submitted That Met QC Criteria: October 1, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Transplantation, Hepatic, Cirrhosis, Bile duct
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 2018/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: de-identified individual participant data for all primary, secondary and tertiary outcome measures will be made available
• IPD Sharing Time Frame: data will be available within 6 months of study completion
• IPD Sharing Access Criteria: data access request will be reviewed by an external independent review panel.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No