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

University of Zurich (UZH) logo

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

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.

Trial contacts and locations

1

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Central trial contact

Michael Linecker, MD; Pierre Alain Clavien, MD PhD

Data sourced from clinicaltrials.gov

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