Effects of Omega-3 Fatty Acids on Outcome After Major Liver Resection

A Randomized, Double-blind Study of the Effects of Omega-3 Fatty Acids (Omegaven™) on Outcome After Major Liver Resection

To study the efficacy and safety of intravenous Omegaven™ (vs. Placebo) in reducing postoperative morbidity and mortality after major liver resection.

With two single doses of Omegaven (pre- and postoperatively) we aim to reduce postoperative complications measured by the CCI (Comprehensive Complication Index) and the Clavien Dindo classification of surgical complications. The study will include adults (more than 18 years) patients requiring liver resection of at least 1 segment or multiple wedge resections (≥3).

Inclusion criteria:

• Requiring liver resection of at least 1 segment or multiple wedge resections (=3)
• > 18 years of age
• No coagulopathy (INR < 1.2, platelets >150'000 x10E3/µl)
• Understands local language

Exclusion criteria:

• Liver resections <1 segment
• Wedge resections (<3)
• Liver cirrhosis
• Coagulopathy (INR > 1.2, platelets < 150'000 x10E3/µl)
• Hypertriglyceridemia (> 5.0 mmol/l)
• Hypersensitivity or allergy to Omegaven™ or any fish oil or lipid emulsions
• Known allergy to egg protein
• Pregnancy
• Nursing women
• Renal failure(estimated GFR < 30 ml/min/1.73m2)
• Medication impairing platelets aggregation
• Cannot understand local language