Biliary Complications in Live Donor Liver Transplantation

NCT03673033 | Completed

• 1 other identifier: 2018/18
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Stricture; Bile Duct Stenosi; Bile Leak; Bile Duct Injury

Keywords

Transplantation, Hepatic, Cirrhosis, Bile duct

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• development of biliary complication in the three months after liver transplantation

  3 months

• development of biliary complication in the six month after liver transplantation

  6 months

Interventions

liver transplantation PROCEDURE

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with live donor liver transplant for any reason

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Cihan Gokler

Malatya, 44090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal invastigator

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: March 10, 2018
• Primary Completion: July 30, 2019
• Study Completion: August 3, 2019
• Last Updated: October 3, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: data will be available within 6 months of study completion
• Access Criteria: data access request will be reviewed by an external independent review panel.

Locations

TU (1)