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

Conditions

Major Liver Surgery

Keywords

at least 1 segment, multiple wedge resections (≥3)

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).

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.

2019-10-1517 citations

10.1016/j.jhep.2019.10.004

"A randomized, double-blind study of the effects of omega-3 fatty acids (Omegaven) on outcome after major liver resection".

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.

2015-08-1417 citations

10.1186/s12876-015-0331-1

Interventions

DRUGOmegaven™

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative complications	1 month after hospital discharge	Complications will be assessed using the Comprehensive Complication Index (CCI) and the Clavien-Dindo complication classification.

Countries

Switzerland

Contacts

Primary ContactMichael Linecker, MD

Michael.Linecker@usz.ch0041 442553300

Backup ContactPierre Alain Clavien, MD PhD

clavien@access.uzh.ch0041 442553300

Outcome results

None listed