Randomised controlled trial of the effects of fish oil emulsion in total parenteral nutrition upon tumour vascularity in patients with hepatic colorectal metastases

Completed

• Conditions: Hepatic colorectal metastases; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN82923678
• Lead Sponsor: niversity Hospitals of Leicester NHS trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-31
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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:
1. Ages 18-80
2. Able to give informed written consent
3. Diagnosis of resectable hepatic colorectal metastases on radiological and laparoscopic appearance (this trial is only assessing operative disease)

Exclusion Criteria

Patients will be excluded from this trial if they have:
1. Malignant disease that is not thought to be potentially operable after laparoscopy
2. Patients already taking fish oil supplements (may interfere with results)
3. Patients already enrolled into other trials (e.g. of chemotherapy)
4. Hypersensitivity to fish, egg or soy protein or to any of the active substances or constituents in the lipid emulsion
5. Hyperlipidaemia
6. Severe blood coagulation disorders
7. Severe renal insufficiency (creatinine >200)
8. Any general contra-indications to infusion therapy ? pulmonary oedema, hyperhydration, decompensated cardiac insufficiency
9. Any unstable medical conditions ? uncontrolled diabetes mellitus, acute myocardial infarction, stroke, embolic disease, metabolic acidosis, sepsis, pancreatitis

Patients meeting the above criteria are excluded as they represent inoperable disease, cases where the results would be invalid (already taking fish oil supplements), contraindications to lipid infusion and unstable medical conditions.

Patients will also be excluded if they have any contraindications to MRI scanning:
1. Cardiac pacemaker
2. Other ferromagnetic metal implants not authorised for use in MRI such as certain types of cerebral aneurysm clips
3. Claustrophobia
4. Body weight or circumference beyond the MRI scanner?s capacity

Study & Design

• Study Type: Interventional
• Study Design: Not specified