The Relationship of Initial Liver Profile and Outcome After Transplantation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02307890|
Recruitment Status : Recruiting
First Posted : December 4, 2014
Last Update Posted : May 2, 2018
|Condition or disease|
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.
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.
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|
|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|
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).
- 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
- 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
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
|Contact: Stephen O'Neillfirstname.lastname@example.org|
|Royal Infirmary of Edinburgh||Recruiting|
|Edinburgh, Midlothian, United Kingdom, EH16 4SA|
|Contact: Stephen O'Neill 07849592113 email@example.com|
|Principal Investigator:||Ewen Harrison||University of Edinburgh|