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

University of Zurich (UZH)

Status and phase: Unknown; Phase 3

Conditions: Major Liver Surgery

Treatments: Drug: Omegaven™

Study type: Interventional

Funder types: Other

Identifiers

NCT01884948

Omegaven - Zurich

Details and patient eligibility

About

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

Full description

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).

Enrollment: 258 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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258 participants in 2 patient groups, including a placebo group

Omegaven™

Active Comparator group

Description:

Omegaven™ (approval number:54750 Swissmedic)- 100ml intravenously. The first dose (Omegaven™ or placebo) is administered in the evening before surgery, the second dose at the beginning of anesthesia. The maximum infusion rate must be adjusted to bodyweight (0.5 ml Omegaven™/kg/hour).

Treatment:

Drug: Omegaven™

NaCl 0.9%

Placebo Comparator group

Description:

100ml of saline is used as a placebo comparator and administered as described above.