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

Recruiting

• Conditions: Colorectal Liver Metastases; Cancer - Liver; Cancer - Bowel - Back passage (rectum) or large bowel (colon)

• Registration Number: ACTRN12606000354583
• Lead Sponsor: Professor Guy J Maddern

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-08-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).]

Secondary Outcome Measures

Name	Time	Method
To investigate the potential correlation of changes over time from neoadjuvant chemotherapy in parenchyma function using 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).]