Status unknownNCT01884948Updated Jun 4, 2014

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

A Phase 3 interventional study of Omegaven™ in Major Liver Surgery, sponsored by University of Zurich. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-04.

Sponsored by University of Zurich · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2014), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 3
Study type: Interventional
Enrollment: 258
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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).

Conditions studied

Major Liver Surgery

Keywords

at least 1 segment
multiple wedge resections (≥3)

In context

Lead sponsor

University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single group
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 258 participants (estimated)

Study arms

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.

Interventions

DrugOmegaven™

What researchers measure

Primary outcomes

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

Study locations

1 of 1 sites recruiting

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

References and documents

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. PubMed 31626819 ↗
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. PubMed 26268565 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 4, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01884948
Lead sponsor: University of Zurich
Responsible party: Sponsor
First posted: Jun 24, 2013
Start date: Jul 2013
Primary completion: Mar 2016 (estimated)
Completion: Mar 2016 (estimated)
Last update: Jun 4, 2014

Study contacts

Michael Linecker, MD

Contact

Michael.Linecker@usz.ch

0041 442553300

Pierre Alain Clavien, MD PhD

Contact

clavien@access.uzh.ch

0041 442553300

Pierre Alain Clavien, MD PhD

principal investigator · University Hospital Zurich, Visceral and Transplantation Surgery

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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