Clinical Trials Logo

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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03673033
Study type Observational [Patient Registry]
Source Inonu University
Contact
Status Completed
Phase
Start date March 10, 2018
Completion date August 3, 2019

See also
  Status Clinical Trial Phase
Completed NCT03115411 - Prospective Evaluation of Winged Biliary Stent Patency in Patients With Benign Biliary Obstruction N/A
Completed NCT02041390 - Effect of Short Message Service Intervention on Stent Removal/Exchange Adherence in Patients With Benign Pancreaticobiliary Diseases N/A
Recruiting NCT01439698 - Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry N/A
Terminated NCT01413386 - Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent N/A
Completed NCT01543256 - WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study N/A
Enrolling by invitation NCT04572711 - Prospective Evaluation of Biliary Tissue Sampling With ERCP
Recruiting NCT03229655 - Evaluation of Sequential Stent Addition vs. Incremental Dilation & Stent Exchange for Management of Anastomotic Biliary Strictures After Liver Transplantation N/A
Completed NCT02916199 - Primary Needle Knife Fistulotomy Versus Conventional Cannulation Method N/A
Recruiting NCT01524146 - Photodynamic Therapy (PDT) Cholangiocarcinoma Registry N/A
Recruiting NCT01522573 - T-EUS for Gastrointestinal Disorders: A Multicenter Registry N/A
Completed NCT02281019 - SpyGlass AMEA Registry
Recruiting NCT04010734 - Primary Cholangioscopy Versus ERCP in the Diagnosis of Biliary Strictures N/A
Not yet recruiting NCT06369896 - Digital Single-operator Cholangioscopy and Intraductal Ultrasound for Nonicteric Biliary Strictures
Recruiting NCT04391153 - FISH in Diagnosis of Biliary Stricture N/A
Active, not recruiting NCT03997994 - DIGEST I Drug Coated Balloon for Biliary Stricture N/A
Enrolling by invitation NCT03951324 - Volumetric Laser Endomicroscopy's (VLE) Diagnostic Accuracy Validation Study: Impact on Clinical Management Study
Unknown status NCT01085747 - Endoscopic Treatment of Biliary Stricture Caused by Chronic Pancreatitis N/A
Completed NCT02105181 - Fully Covered Self-expandable Metal Stents (FCMS) in Benign Biliary Strictures N/A
Recruiting NCT05761483 - Endoscopic Management of Non-anastomotic Biliary Strictures Following Liver Transplantation.
Recruiting NCT06277531 - Evaluation of diagnostiC Capacity of eccDNAs as Biomarkers in Indetermined biLiary Stricture(ECCBILE)