Protocol for the CoNoR Study: A prospective multi-step study of the potential added benefit of two novel assessment tools in colorectal liver metastases technical resectability decision-making. Issue 3 (30th March 2023)

• Record Type: Journal Article
• Authors: Parmar, Kat L; O'Reilly, Derek; Valle, Juan; Braun, Michael; Malcomson, Lee; Jones, Robert P; Balaa, Fady; Rees, Myrddin; Welsh, Fenella K S; Filobbos, Rafik; Renehan, Andrew G
• Is Part Of: BMJ open. Volume 13:Issue 3(2023)
• Publication Date: 2023-03-30
• Subjects: Hepatobiliary surgery -- Gastrointestinal tumours -- Gastrointestinal tumours; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2021-059369
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: Liver resection is the only curative treatment for colorectal liver metastases (CLM). Resectability decision-making is therefore a key determinant of outcomes. Wide variation has been demonstrated in resectability decision-making, despite the existence of criteria. This paper summarises a study protocol to evaluate the potential added value of two novel assessment tools in assessing CLM technical resectability: the Hepatica preoperative MR scan (MR-based volumetry, Couinaud segmentation, liver tissue characteristics and operative planning tool) and the LiMAx test (hepatic functional capacity). Methods and analysis: This study uses a systematic multistep approach, whereby three preparatory workstreams aid the design of the final international case-based scenario survey: Workstream 1: systematic literature review of published resectability criteria. Workstream 2: international hepatopancreatobiliary (HPB) interviews. Workstream 3: international HPB questionnaire. Workstream 4: international HPB case-based scenario survey. The primary outcome measures are change in resectability decision-making and change in planned operative strategy, resulting from the novel test results. Secondary outcome measures are variability in CLM resectability decision-making and opinions on the role for novel tools. Ethics and dissemination: The study protocol has been approved by a National Health Service Research Ethics Committee and registered with the Health Research Authority. Dissemination will be via international and national conferences. Manuscripts will be published. Registration details: The CoNoR Study is registered with ClinicalTrials.gov (registration number NCT04270851 ). The systematic review is registered on the PROSPERO database (registration number CRD42019136748).