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

A Randomized, Double-blind Study of the Effects of Omega-3 Fatty Acids (Omegaven™) on Outcome After Major Liver Resection

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

Study Overview

• Status: Unknown
• Conditions: Major Liver Surgery
• Intervention / Treatment: Drug: Omegaven™

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 Type: Interventional
• Enrollment (Anticipated): 258
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Michael Linecker, MD; Phone Number: 0041 442553300; Email: Michael.Linecker@usz.ch
• Study Contact Backup: Name: Pierre Alain Clavien, MD PhD; Phone Number: 0041 442553300; Email: clavien@access.uzh.ch

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • Recruiting
      • University Hospital Zurich, Visceral and Transplantation Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Drug: Omegaven™
Placebo Comparator: NaCl 0.9%; 100ml of saline is used as a placebo comparator and administered as described above.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Pierre Alain Clavien, MD PhD, University Hospital Zurich, Visceral and Transplantation Surgery

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Omegaven

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: June 14, 2013
• First Submitted That Met QC Criteria: June 21, 2013
• First Posted (Estimate): June 24, 2013

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: at least 1 segment; multiple wedge resections (≥3)
• Other Study ID Numbers: Omegaven - Zurich