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

Major Liver Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01884948
• Other study ID #: Omegaven - Zurich
• Status: Recruiting
• Phase: Phase 3
• First received: June 14, 2013
• Last updated: June 3, 2014
• Start date: July 2013
• Est. completion date: March 2016

Study information

• Verified date: June 2014
• Source: University of Zurich
• Contact: Michael Linecker, MD
• Phone: 0041 442553300
• Email: Michael.Linecker[@]usz.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 258
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Major Liver Surgery

Intervention

Drug:
• Omegaven™

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Visceral and Transplantation Surgery	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	Complications will be assessed using the Comprehensive Complication Index (CCI) and the Clavien-Dindo complication classification.	1 month after hospital discharge	No

External Links

•   Omegaven