Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF Study
Introduction Preoperative chemotherapy in patients undergoing resection for colorectal liver metastases (CLM) improves oncological outcomes. However, chemotherapy-associated liver injury (occurring in two patterns: vascular and fat deposition) is a real clinical concern prior to hepatic resection. A...
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BMJ Publishing Group
2020-09-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/9/e027630.full |
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| author | Katharine Cresswell Juan W Valle Michael Braun Kat L Parmar Derek O'Reilly Jo H Naish Steve R Williams William K Lloyd Lee Malcomson Colin Bamford Andrew G Renehan |
| author_facet | Katharine Cresswell Juan W Valle Michael Braun Kat L Parmar Derek O'Reilly Jo H Naish Steve R Williams William K Lloyd Lee Malcomson Colin Bamford Andrew G Renehan |
| author_sort | Katharine Cresswell |
| collection | DOAJ |
| description | Introduction Preoperative chemotherapy in patients undergoing resection for colorectal liver metastases (CLM) improves oncological outcomes. However, chemotherapy-associated liver injury (occurring in two patterns: vascular and fat deposition) is a real clinical concern prior to hepatic resection. After major liver resection, regeneration of the residual liver is a prerequisite for recovery and avoidance of liver failure, but this regenerative capacity may be hindered by chemotherapy. Thus, there is a need to predict for this serious complication. Over the past two decades, several tests and derived indices have been developed, which have failed to achieve clinical utility, mainly as they were indirect measurements of liver function. Here, we will use a novel test of liver function (the liver maximum capacity (LiMAx) test), and measure liver fat using MRI.Methods and analysis This prospective study will assess changes in liver function longitudinally, measured by the LiMAx test, and liver fat, measured by advanced MRI using both MR spectroscopy and the modified Dixon method, in up to 35 patients undergoing preoperative chemotherapy for CLM. The primary outcomes will be the changes in liver function and fat compared with baseline prechemotherapy measurements. Secondary outcome measures include: routinely measured liver function blood tests, anthropometric measurements, postoperative histology and digital quantification of fat, postoperative complications and mortality and quality of life.Ethics and dissemination The study was approved by a National Health Service Research Ethics Committee and registered with the Health Research Authority. Dissemination will be via international and national conferences and the National Institute for Health Research network. Manuscripts will be published.Trial registration number This study is registered online at www.clinicaltrials.gov (registration number NCT03562234). |
| format | Article |
| id | doaj-art-1dcb9c27135c4881b64cccfffd15d4d2 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-1dcb9c27135c4881b64cccfffd15d4d22025-01-08T23:00:12ZengBMJ Publishing GroupBMJ Open2044-60552020-09-0110910.1136/bmjopen-2018-027630Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF StudyKatharine Cresswell0Juan W Valle1Michael Braun2Kat L Parmar3Derek O'Reilly4Jo H Naish5Steve R Williams6William K Lloyd7Lee Malcomson8Colin Bamford9Andrew G Renehan10Public Programmes Team, Research and Innovation Division, Manchester University NHS Foundation Trust, Manchester, UKMedical Oncology, The Christie NHS Foundation Trust/University of Manchester, Manchester, UKOncology, Christie NHS Foundation Trust, Manchester, UKDivision of Cancer Sciences, The University of Manchester, Manchester, UKHepatobiliary Surgery, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UKInstitute of Cardiovascular Sciences, University of Manchester, Manchester, UKCentre for Imaging Sciences, University of Manchester, Manchester, UKCentre for Imaging Sciences, University of Manchester, Manchester, UKNIHR Manchester Biomedical Research Centre, Manchester, UKCancer Patient and Public Advisory Group, NIHR Manchester Biomedical Research Centre, Manchester, UKDivision of Cancer Sciences, The University of Manchester, Manchester, UKIntroduction Preoperative chemotherapy in patients undergoing resection for colorectal liver metastases (CLM) improves oncological outcomes. However, chemotherapy-associated liver injury (occurring in two patterns: vascular and fat deposition) is a real clinical concern prior to hepatic resection. After major liver resection, regeneration of the residual liver is a prerequisite for recovery and avoidance of liver failure, but this regenerative capacity may be hindered by chemotherapy. Thus, there is a need to predict for this serious complication. Over the past two decades, several tests and derived indices have been developed, which have failed to achieve clinical utility, mainly as they were indirect measurements of liver function. Here, we will use a novel test of liver function (the liver maximum capacity (LiMAx) test), and measure liver fat using MRI.Methods and analysis This prospective study will assess changes in liver function longitudinally, measured by the LiMAx test, and liver fat, measured by advanced MRI using both MR spectroscopy and the modified Dixon method, in up to 35 patients undergoing preoperative chemotherapy for CLM. The primary outcomes will be the changes in liver function and fat compared with baseline prechemotherapy measurements. Secondary outcome measures include: routinely measured liver function blood tests, anthropometric measurements, postoperative histology and digital quantification of fat, postoperative complications and mortality and quality of life.Ethics and dissemination The study was approved by a National Health Service Research Ethics Committee and registered with the Health Research Authority. Dissemination will be via international and national conferences and the National Institute for Health Research network. Manuscripts will be published.Trial registration number This study is registered online at www.clinicaltrials.gov (registration number NCT03562234).https://bmjopen.bmj.com/content/10/9/e027630.full |
| spellingShingle | Katharine Cresswell Juan W Valle Michael Braun Kat L Parmar Derek O'Reilly Jo H Naish Steve R Williams William K Lloyd Lee Malcomson Colin Bamford Andrew G Renehan Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF Study BMJ Open |
| title | Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF Study |
| title_full | Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF Study |
| title_fullStr | Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF Study |
| title_full_unstemmed | Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF Study |
| title_short | Prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy: protocol for the CLiFF Study |
| title_sort | prospective study of change in liver function and fat in patients with colorectal liver metastases undergoing preoperative chemotherapy protocol for the cliff study |
| url | https://bmjopen.bmj.com/content/10/9/e027630.full |
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