OMEGAVEN Study


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

 

Background

The body is dependent on the exogenous supply of omega-3 polyunsaturated fatty acids (n3-PUFA). These essential fatty acids are key players in regulating metabolic signaling but also exert anti-inflammatory and anti-carcinogenic properties. The liver is a major metabolic organ involved in fatty acid metabolism. Under experimental conditions, n3-PUFA exert beneficial effect on hepatic steatosis, regeneration and inflammatory insults such as ischemic injury after surgery. Some of these effects have also been observed in human subjects. However, it is unclear whether perioperative administration of n3-PUFA is sufficient to protect the liver from ischemic injury. Therefore, we designed a randomized controlled trial (RCT) assessing n3-PUFA (pre-) conditioning strategies in patients scheduled for liver surgery.
 

Methods/Design

The Omegaven™ trial is a multi-centric, double-blind, randomized, placebo- controlled trial applying two single doses of Omegaven™ or placebo on 258 patients undergoing major liver resection. Primary endpoints are morbidity and mortality one month after hospital discharge, defined by the Clavien- Dindo classification of surgical complications (Ann Surg 240(2):205–13, 2004) as well as the Comprehensive Complication Index (CCI) (Ann Surg 258(1):1–7, 2013). Secondary outcome variables include length of Intensive Care Unit (ICU) and hospital stay, postoperative liver function tests, fatty acid and eicosanoid concentration, inflammatory markers in serum and in liver tissue. An interim analysis is scheduled after the first 30 patients per randomization group.
 

Discussion

Long-term administration of n3-PUFA have a beneficial effect on metabolism and hepatic injury.
Patients often require surgery without much delay, thus long-term n3-PUFA uptake is not possible. Also, lack of compliance may lead to incomplete n3-PUFA substitution. Hence, perioperative Omegaven™ may provide an easy and controllable way to ensure hepaative application of tic protection.
 

Trial registration

ClinicalTrial.gov: ID: NCT01884948, registered June 14, 2013; Institution Ethical Board 
 

Approval

KEK-ZH-Nr. 2010–0038; Swissmedic Notification: 2012DR3215
 

Keywords

Omega3- polyunsaturated fatty acids (n3-PUFA), Omegaven™, Major liver surgery, Clavien-Dindo complication score, Comprehensive Complication Index (CCI)

 

Informationen

Ihre Ansprechpartner bei Fragen:


Prof. Pierre-Alain Clavien und Dr. med. Michael Linecker
Klinik für Viszeral- und Transplantationschirurgie
UniversitätsSpital Zürich

Tel. +41 (0)44 255 33 00
michael.linecker@usz.ch