Potentially resectable hepatic (liver) metastases from colorectal (bowel) cancer.
Conditions
Interventions
Trade Name: Lipidem
Product Name: Lipidem
Product Code: N/A
Pharmaceutical Form: Solution for infusion
Trade Name: Lipofundin MCT/LCT 2
Sponsors
University Hospitals of Leicester NHS Trust Research & Development Department
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with hepatic colorectal metastases, in whom the disease is assessed as amenable to curative resection will be eligible for the study. The inclusion criteria will be: · Aged 18-80 · Able to give informed written consent · Diagnosis of respectable hepatic colorectal metastases on radiological and laparoscopic appearances Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will be excluded from this trial if they have: · Hypersensitivity to fish-, egg-, or soy protein, or to any of the active substances or constituents in the lipid emulsion · Hyperlipidaemia · Severe blood coagulation disorders · Severe renal insufficiency (Creatinine >200) · Any general contra-indications to infusion therapy – pulmonary oedema, hyperhydration, decompensated cardiac insufficiency · Any unstable medical conditions – uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis · Patients undergoing conventional neo-adjuvant chemotherapy . Cardiac pacemaker or any other ferromagnetic implant not authorised for use in MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this trial is to assess the effect of omega-3 fatty acids upon hepatic colorectal metastases in a pilot study. The primary outcome measure will be change in gadolinium chelate enhancement on Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI) between study entry and exit, which is a marker of tumour vascularity. ; Secondary Objective: · Changes in serum levels of Leukotreines B5, B4, TNF-a and IL-6 · Measured omega-3 FA levels in cellular membranes of blood leukocytes · Changes in vascular endothelial growth factor levels (VEGF) · Changes in COX-2 activity in patient leukocytes · Omega-3 levels in resected tumour ;Primary end point(s): The primary end point is each patient having completed 3 days of total parenteral nutrition supplemented with (Lipidem) or without (Lipofundin) omega-3 and having had 3 DCE-MRI scans as per the protocol, prior to proceeding to hepatic resection. | — |
Countries
United Kingdom
Outcome results
None listed