None listed
Conditions
Brief summary
The purpose of this stage of the study is to find out how well the livers of patients who have undergone chemotherapy and/or a liver resection regenerate after surgery compared to the livers of patients who have not undergone chemotherapy treatment. We are conducting this study because post-surgery assessment of liver function and the prediction of how well the liver functions after surgery in patients who have undergone chemotherapy and/or liver resection has not been examined. We will find this information out by conducting a liver function test using Indocyanine Green Clearance dye (ICG). This test provides us with an indication of how well your liver is functioning at a point in time.
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 st
·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
Sponsors
Professor Guy J Maddern
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Written, informed consent to participate in trial.·Patients undergoing neoadjuvant chemotherapy for resectable/unresectable colorectal metastases or, ·Patients undergoing liver resection for resectable colorectal metastases. ·Patients who have either never had chemotherapy or who have undergone chemotherapy previously (excluding 12 months prior to enrolment in this trial).
Exclusion criteria
Patients who are pregnant or who are breast-feeding. It is unknown if ICG can cause harm to a foetus or baby.·A history of allergy to iodides as ICG contains sodium iodide and should be used with caution. ·Patients whom the investigator does not see fit to be involved in this study. ·Patients who have undergone chemotherapy in the last 12 months.·Patients who are unable to give informed consent.Precautions·Radioactive iodine uptake studies should not be performed for at least a week following the use of ICG.
Outcome results
None listed