Biliary Complications in Live Donor Liver Transplantation

Biliary Stricture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673033
• Other study ID #: 2018/18
• Status: Completed
• Start date: March 10, 2018
• Est. completion date: August 3, 2019

Study information

• Verified date: September 2018
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 3, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Injury
• Bile Duct Stenosi
• Bile Leak
• Biliary Stricture
• Constriction, Pathologic

Intervention

Procedure:
• liver transplantation
calculation of hot and cold ischemia durations from donor artery cut-off time in liver transplantation

Locations

Country	Name	City	State
Turkey	Cihan Gokler	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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