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

Phase 3

• Conditions: Major Liver Surgery
• Interventions: Drug: Omegaven™

• Registration Number: NCT01884948
• Lead Sponsor: University of Zurich

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).

Study Timeline

• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-21
• Study First Posted: 2013-06-24
• Study Start: 2013-07
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04
• Primary Completion: 2016-03
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omegaven™	Omegaven™	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).

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Zurich, Visceral and Transplantation Surgery; 🇨🇭 Zurich, ZH, Switzerland