The Effects of Neoadjuvant Chemotherapy for Colorectal Liver Metastases on Functional Hepatic Reserves as Assessed by Indocyanine Green Clearance - A Pilot Study.

Interventions: ·Stage one involves patients that have colorectal liver metastases and who need to undergo chemotherapy to help reduce the size of liver metastases. These patients may or may not proceed to a liver resection. The treating doctor will monitor each patient’s progress and determine if the patient is medically stable to undergo such an invasive procedure, once chemotherapy treatment has ceased. The patients who proceed to liver resection are given the opportunity to take part in stage two of this study. Chemotherapy would most likely be 5-Fluorouracil, Leucovorin and Oxaliplatin (FOLFOX). Dose and mode are dependant on the patients treatment as deemed appropriate by the oncologist. Duration: Approximately 9 months
·Stage two involves comparing patients who have had chemotherapy treatment with patients who have not had chemotherapy for their colorectal liver metastases. This stage is designed to see how quickly the liver regenerates after chemotherapy and surgery compared to patients who have not undergone chemotherapy. Patients from stage one who are able to have liver resection surgery will be given the opportunity to join stage two of the study. The groups of patients for Stage 2 resection are discussed at a weekly Upper GI meeting at the QEH and at this time they are either deemed eligible or not. Duration: Approximately 6 months
Primary outcome(s): To determine the optimal time for liver regeneration and liver resection in patients who have undergone neoadjuvant chemotherapy for colorectal liver metastases, as assessed by Indocyanine Green Clearance dye.[ The outcome will be assessed after 10 patients to ascertain if the trial is producing any results (given that it is a pilot study).]
Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy