Liver Metastasis Colon Cancer Clinical Trial
Official title:
Application of High-Dose Insulin Therapy Using a Hyperinsulinemic Normoglycemic Clamp to Improve Liver Function and Regeneration
NCT number | NCT06126419 |
Other study ID # | 2023-8880 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 8, 2023 |
Est. completion date | July 2025 |
The primary objective of this interventional study is determine if the future liver remnant can be optimized by improving liver function pre-operatively in patients who are scheduled for major hepatectomy. The main questions it aims to answer are: 1. Does high-dose insulin therapy improve liver function in the pre-operative setting? 2. What is the effect of high-dose insulin therapy on liver function and liver regeneration after a liver venous deprivation (LVD) procedure? 3. What is the relationship between volume hypertrophy and function in the regenerating liver? Participants will receive a 6-hour infusion of insulin and dextrose to maintain a hyperinsulinemic-normoglycemic state in the weeks prior to planned liver surgery to assess its effect on liver function measured by 99m-Tc-Mebrofenin hepatobiliary scintigraphy.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | July 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years old - Candidate for major liver resection - Resectable colorectal liver metastasis Exclusion Criteria: - Inability to give consent - Type 1 diabetes mellitus - Uncontrolled blood glucose levels (fasting level > 10 mmol/L) - Unresectable colorectal liver metastasis - Extrahepatic metastatic disease that is unresectable |
Country | Name | City | State |
---|---|---|---|
Canada | McGill Univeristy Health Centre | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver function improvement after high-dose insulin therapy measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS). | 99mTc-Mebrofenin HBS is a diagnostic nuclear medicine imaging procedure used to evaluate liver function by measuring radiotracer uptake and excretion. The outcome will be evaluating a measurable increase in 99mTc-Mebrofenin (measured %/min/meter^2) from baseline scan to post-treatment scan. | Baseline to 24-hours post treatment | |
Primary | Liver function improvement after high-dose insulin therapy after LVD measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS). | 99mTc-Mebrofenin HBS is a diagnostic nuclear medicine imaging procedure used to evaluate liver function by measuring radiotracer uptake and excretion. The outcome will be evaluating a measurable increase in 99mTc-Mebrofenin (measured %/min/meter^2) from baseline scan to post-treatment scan. | Baseline to 7 days post treatment | |
Primary | Liver regeneration improvement after high-dose insulin therapy after LVD measured CT volumetry | The volume of the liver can be measured from liver protocoled CT scans | Baseline to 7 days post treatment |
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