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

Abstract

BackgroundThe 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/DesignThe 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.DiscussionLong-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 registrationClinicalTrial.gov: ID: NCT01884948, registered June 14, 2013; Institution Ethical Board Approval: KEK-ZH-Nr. 2010–0038; Swissmedic Notification: 2012DR3215.

Dietary Pattern and Macronutrients Profile on the Variation of Inflammatory Biomarkers: Scientific Update

“…The proportion and type of fats included in the diet influence the degree of inflammation and the risk of NCD. In this context, the intake of polyunsaturated fatty acids (PUFA), particularly the long-chain ones from the w-3 series (n-3 PUFA), is related to the reduction of the risk of cardiovascular diseases and death due to its anti-inflammatory potential [ 51 – 54 ]. Diets high in monounsaturated fatty acids (MUFA) have also been highlighted for their potential in reducing inflammation due to the lower expression of genes related to the synthesis of IL-6 [ 10 , 55 ].…”

Omega-3 Fatty Acids Protect Fatty and Lean Mouse Livers After Major Hepatectomy

“…This study should also inform on the V3FA activities in I/R, regeneration, and steatosis in patients. 46 The use of V3FA as a measure to expand the application of surgery to fatty liver, or lean liver requiring extended resection, comes with several advantages; the pre-operative administration of V3FA is simple, either as a food supplement or via intravenous injection (Omegaven). Therefore, little issues with compliance are expected, unlike for the currently recommended NAFLD treatment, that is, exercise combined with caloric restriction.…”

European Society of Gynaecological Oncology quality indicators for surgical treatment of cervical cancer

“…68 These trials showed a greater ability to detect differences between treatment effects than classic endpoints such as 'any complication' or 'major complication' defined according to the Clavien-Dindo classification. The index has been used in large multi-centric studies, [69][70][71][72][73][74][75][76][77] notably as a benchmark endpoint for major surgery. 70 Exploring the potential added value of the comprehensive comprehensive index to standard assessment of postoperative morbidity, and to clarify potential controversies for its application, Clavien et al 78 reported that it yielded substantial additional value to the Clavien-Dindo classification in patients with more than one complication.…”