Major Liver SurgeryPhase 3NCT01884948
Effects of Omega-3 Fatty Acids on Outcome After Major Liver Resection
A Phase 3 study testing Omegaven™ in people with Major Liver Surgery, run by University of Zurich at 1 site in Switzerland.
Trial summary
To study the efficacy and safety of intravenous Omegaven™ (vs. Placebo) in reducing postoperative morbidity and mortality after major liver resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Liver Surgery
- What is being tested?
- Omegaven™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 258 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2013to Mar 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich, Visceral and Transplantation Surgery
Zurich, Canton of Zurich, 8091
About this study
Official title: 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.
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
- Major Liver Surgery
- Being tested
- Omegaven™
- Keywords
- at least 1 segment, multiple wedge resections (≥3)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omegaven™Drug
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Omegaven™ |
| NaCl 0.9% | Placebo comparator | 100ml of saline is used as a placebo comparator and administered as described above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Complications will be assessed using the Comprehensive Complication Index (CCI) and the Clavien-Dindo complication classification.
Measured: 1 month after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Liver SurgeryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Alain Clavien, MD PhD, Principal investigator, University Hospital Zurich, Visceral and Transplantation Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01884948
- Sponsor's protocol ID
- Omegaven - Zurich
- Status last verified
- Jun 2014
- First submitted
- 14 Jun 2013
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
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 31626819Linecker 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study of the Effects of Omega-3 Fatty Acids (Omegaven™) on Outcome After Major Liver Resection
- ClinicalTrials.gov ID
- NCT01884948
- Acronym / sponsor ID
- Omegaven - Zurich
- Conditions
- Major Liver Surgery
- Keywords
- at least 1 segment, multiple wedge resections (≥3)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 24 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omegaven™ | Active comparator | Drug: 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). |
| NaCl 0.9% | Placebo comparator | –100ml of saline is used as a placebo comparator and administered as described above. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- Liver resections <1 segment
- Wedge resections (<3)
- Liver cirrhosis
- Coagulopathy (INR > 1.2, platelets < 150'000 x10E3/µl)
- Hypertriglyceridemia (> 5.0 mmol/l)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omegaven™ | Drug | Omegaven™ |
Primary outcome
Postoperative complications
Time frame: 1 month after hospital discharge
Complications will be assessed using the Comprehensive Complication Index (CCI) and the Clavien-Dindo complication classification.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
- Derived from this study: PubMed 31626819Linecker 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.
- Derived from this study: PubMed 26268565Linecker 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.
- OmegavenLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Alain Clavien, MD PhD principal investigator
University Hospital Zurich, Visceral and Transplantation Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omegaven™ in people with Major Liver Surgery, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Linecker, MD (0041 442553300, Michael.Linecker@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 1 month after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01884948, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014.