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The Relationship of Initial Liver Profile and Outcome After Transplantation

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ClinicalTrials.gov Identifier: NCT02307890
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : May 2, 2018
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

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
Liver Failure

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 Type : Observational
Estimated 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 : August 2014
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. Changes in hepatobiliary miRNA expression during liver transplantation in liver grafts that develop ischemic cholangiopathy following liver transplantation [ Time Frame: 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 [ Time Frame: 12 months ]
    Assessed by senescence markers in liver and bile duct samples taken during different stages of liver transplantation and correlation with clinical outcomes


Biospecimen Retention:   Samples With DNA
Liver and bile duct


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Liver transplantation group
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307890


Contacts
Contact: Stephen O'Neill 07849592113 stephenoneill@doctors.org.uk

Locations
United Kingdom
Royal Infirmary of Edinburgh Recruiting
Edinburgh, Midlothian, United Kingdom, EH16 4SA
Contact: Stephen O'Neill    07849592113    stephenoneill@doctors.org.uk   
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
Principal Investigator: Ewen Harrison University of Edinburgh

Publications:
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02307890     History of Changes
Other Study ID Numbers: 2014/097
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Edinburgh:
Liver Transplantation

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases