Assessment of subclinical allograft damage
Research type
Research Study
Full title
Assessment of subclinical allograft damage following liver transplantation
IRAS ID
259384
Contact name
Alberto Sanchez-Fueyo
Contact email
Sponsor organisation
Kings College London
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Routine serum markers of liver injury such as aspartate and alanine aminotransferases (AST, ALT), gamma-glutamyl-transpeptidase (GGT) or alkaline phosphatase (AP) are known to be insensitive and nonspecific indicators of allograft rejection in liver transplantation (LT). The performance of protocol, or surveillance, liver biopsies have been proposed as a more accurate strategy to assess graft function and potentially to personalize the use of immunosuppression. This is based on a multiplicity of studies showing that a very large proportion of patients with normal liver biochemistry tests exhibit clinically significant histological lesions, with portal inflammation (with/without interface activity and various degrees of fibrosis) not attributable to recognizable causes such as viral infection or autoimmune hepatitis being the most frequently described abnormality. A recent report indicates that at the molecular level these inflammatory lesions closely resemble what is observed in rejection. Despite these evidences, the clinical utility of protocol liver biopsies remains contentious. This is mainly due to the lack of longitudinal studies assessing the extent to which subclinical inflammatory lesions progress over time and eventually result in liver failure.
In the current study, we propose to collect demographic, clinical and histological data from liver transplant recipients who are undergoing (or have already undergone) liver biopsies to assess the presence of subclinical allograft damage as part of their routine clinical care. We will perform detailed histological analysis and correlate the information with clinical data and previous liver biopsies to understand which parameters influence the progression of subclinical allograft damage and whether unfavourable histological outcomes can be anticipated.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0078
Date of REC Opinion
8 Jul 2019
REC opinion
Unfavourable Opinion