Ignite Creation Date:
2024-05-06 @ 3:30 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02307890
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2014-11-24
Brief Title:
The Relationship of Initial Liver Profile and Outcome After Transplantation
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
The Relationship of Hepatobiliary microRNA Expression Profile and Clinical Outcome in Liver Transplantation
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None