|Title||Study protocol: HepaT1ca - an observational clinical cohort study to quantify liver health in surgical candidates for liver malignancies.|
|Authors||Mole, D.J., Fallowfield, J.A., Kendall, T.J., Welsh, F., Semple, S.I., Bachtiar, V., Kelly, M., Wigmore, S.J., Garden, O.J., Wilman, H.R., Banerjee, R., Rees, M. and Brady, M.|
With ethical approval and fully-informed consent, individuals considering liver surgery for primary or secondary cancer will undergo clinical assessment, blood sampling, and LiverMultiScan™multiparametric MRI before and after surgical liver resection or TACE. In nested cohorts of individuals undergoing chemotherapy prior to surgery, or those undergoing portal vein embolization (PVE) as an adjunct to surgery, an additional testing session prior to commencement of treatment will occur. Tissue will be examined histologically and by immunohistochemistry. Pre-operative liver health assessment scores and the post-operative risk scores will be correlated to define the ability of LiverMultiScan™to predict the risk of post-operative morbidity and mortality. Because technology performance in this setting is unknown, a pragmatic sample size will be used. For the primary outcome, n = 200 for the main cohort will allow detection of a minimum correlation coefficient of 0.2 with 5% significance and power of 80%.
|Journal citation||18, p. 890|
|Digital Object Identifier (DOI)||doi:10.1186/s12885-018-4737-3.|
|Web address (URL)||https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6136162/|
|Published||12 Sep 2018|
|License||CC BY 4.0|