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The Relationship of Initial Liver Profile and Outcome After Transplantation

Sponsor
University of Edinburgh (Other)
Overall Status
Unknown status
CT.gov ID
NCT02307890
Collaborator
NHS Lothian (Other)
100
Enrollment
1
Location
72
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Donation after cardiac death (DCD) livers are increasingly utilised in liver transplantation but concerns exist regarding negative results. Ischemic cholangiopathy (IC) is damage to one or more bile ducts probably caused by inadequate blood flow or a failure of biliary epithelium to regenerate. It typically presents weeks to months after liver transplantation, is often refractory to treatment and can result in a requirement for re-transplantation. Although IC is more common following DCD liver transplantation, it is otherwise very difficult to predict and the underlying pathogenesis is poorly understood. The aim of this study is to correlate microRNA (miRNA) levels and markers of senescence in liver and bile duct biopsies taken during liver transplantation with the incidence of IC following liver transplantation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Study population

    Tissue from all deceased adult liver transplant grafts will be collected. The test samples will be selected from procedures were the liver transplant recipient has developed IC. The control samples will include tissues from procedures were the transplant recipient had an uncomplicated outcome. There will be matching of test samples and control samples based on a range of clinical factors.

    Consent

    Standard consent for organ donation documentation has a general consent to research section. Due to the small risk of damage to blood vessels when taking samples the liver transplant recipient will also be consented for these procedures to take place.

    Tissue sampling

    Liver and bile duct samples from each graft will be obtained at various different time points during liver transplant procedures.

    Processing of specimens

    Following removal of the specimens, samples will be divided then added to RNAlater (Life Technologies, Paisley, UK), 10% formaldehyde or will be snap frozen. At a later time point samples will be analysed.

    Definition of ischemic cholangiopathy

    IC will be defined as strictures, dilatations, or irregularities of the intra- or extrahepatic bile ducts of the liver graft. Isolated strictures at the bile duct anastomosis will be excluded. The diagnosis will be based on at least one adequate imaging study of the biliary tree, after exclusion of hepatic artery thrombosis by Doppler ultrasound, computed tomography or conventional angiography.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Relationship of Hepatobiliary microRNA Expression Profile and Clinical Outcome in Liver Transplantation
    Study Start Date :
    Aug 1, 2014
    Anticipated Primary Completion Date :
    Aug 1, 2019
    Anticipated Study Completion Date :
    Aug 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Liver transplantation group

    Participants will include all deceased adult liver transplant donors (>16 years of age) whose livers are being utilised for transplantation in the Scottish Liver Transplant Unit in the Royal Infirmary of Edinburgh. Exclusion criteria will include paediatric liver transplant donors (<16 years of age).

    Outcome Measures

    Primary Outcome Measures

    1. Changes in hepatobiliary miRNA expression during liver transplantation in liver grafts that develop ischemic cholangiopathy following liver transplantation [12 months]

      Assessed by sequencing of liver and bile duct samples taken during different stages of liver transplantation and correlation with clinical outcomes

    Secondary Outcome Measures

    1. Changes in hepatobiliary senescence during liver transplantation in liver grafts that develop ischemic cholangiopathy following liver transplantation [12 months]

      Assessed by senescence markers in liver and bile duct samples taken during different stages of liver transplantation and correlation with clinical outcomes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All deceased adult liver transplant donors (>16 years of age) whose livers are being utilised for transplantation in the Scottish Liver Transplant Unit in the Royal Infirmary of Edinburgh
    Exclusion Criteria:
    • Paediatric liver transplant donors (<16 years of age).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Infirmary of Edinburgh Edinburgh Midlothian United Kingdom EH16 4SA

    Sponsors and Collaborators

    • University of Edinburgh
    • NHS Lothian

    Investigators

    • Principal Investigator: Ewen Harrison, University of Edinburgh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Edinburgh
    ClinicalTrials.gov Identifier:
    NCT02307890
    Other Study ID Numbers:
    • 2014/097
    First Posted:
    Dec 4, 2014
    Last Update Posted:
    May 2, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by University of Edinburgh
    Liver Transplantation
    Additional relevant MeSH terms:
    Liver Failure

    Study Results

    No Results Posted as of May 2, 2018