Clinical trial NCT01884948: Effects of Omega-3 Fatty Acids on Outcome After Major Liver Resection
Official title: A Randomized, Double-blind Study of the Effects of Omega-3 Fatty Acids (Omegaven™) on Outcome After Major Liver Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Major Liver Surgery
Keywords: at least 1 segment
multiple wedge resections (≥3)
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 258
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative complications
timeFrame: 1 month after hospital discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Visceral and Transplantation Surgery
state: ZH
Study officials:
affiliation: University Hospital Zurich, Visceral and Transplantation Surgery
name: Pierre Alain Clavien, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Linecker M, Botea F, Aristotele Raptis D, Nicolaescu D, Limani P, Alikhanov R, Kim P, Wirsching A, Kron P, Schneider MA, Tschuor C, Kambakamba P, Oberkofler C, De Oliveira ML, Bonvini J, Efanov M, Graf R, Petrowsky H, Khatkov I, Clavien PA, Popescu I. Perioperative omega-3 fatty acids fail to confer protection in liver surgery: Results of a multicentric, double-blind, randomized controlled trial. J Hepatol. 2020 Mar;72(3):498-505. doi: 10.1016/j.jhep.2019.10.004. Epub 2019 Oct 15.
citation: Linecker M, Limani P, Botea F, Popescu I, Alikhanov R, Efanov M, Kim P, Khatkov I, Raptis DA, Tschuor C, Beck-Schimmer B, Bonvini J, Wirsching A, Kron P, Slankamenac K, Humar B, Graf R, Petrowsky H, Clavien PA. "A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven) on outcome after major liver resection". BMC Gastroenterol. 2015 Aug 14;15:102. doi: 10.1186/s12876-015-0331-1.