NCT01884948

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
258

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 24, 2013

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 4, 2014

Status Verified

June 1, 2014

Enrollment Period

2.7 years

First QC Date

June 14, 2013

Last Update Submit

June 3, 2014

Conditions

Major Liver Surgery

Keywords

at least 1 segmentmultiple wedge resections (≥3)

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    Complications will be assessed using the Comprehensive Complication Index (CCI) and the Clavien-Dindo complication classification.

    1 month after hospital discharge

Study Arms (2)

Omegaven™

ACTIVE COMPARATOR

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™

NaCl 0.9%

PLACEBO COMPARATOR

100ml of saline is used as a placebo comparator and administered as described above.

Interventions

Omegaven™DRUG
Omegaven™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Visceral and Transplantation Surgery

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

Related Publications (2)

  • 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.

    PMID: 31626819DERIVED

  • 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.

    PMID: 26268565DERIVED

Related Links

MeSH Terms

Interventions

fish oil triglycerides

Study Officials

  • Pierre Alain Clavien, MD PhD

    University Hospital Zurich, Visceral and Transplantation Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Linecker, MD

CONTACT

0041 442553300Michael.Linecker@usz.ch

Pierre Alain Clavien, MD PhD

CONTACT

0041 442553300clavien@access.uzh.ch

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2013

First Posted

June 24, 2013

Study Start

July 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 4, 2014

Record last verified: 2014-06

Locations

CH(1)