Gastric TumorPhase 4NCT01819961
Parenteral Fish Oil in Major Laparoscopic Abdominal Surgery
A Phase 4 study testing MCT/LCT and fish oil and MCT/LCT in people with Gastric Tumor and Pancreatic Tumor, run by Wei Zhou at 1 site in China.
Trial summary
The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Gastric Tumor, Pancreatic Tumor, Liver Tumor
- What is being tested?
- MCT/LCT and fish oil and MCT/LCT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Dec 2013
- Phase
- Phase 4
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition
Who cannot join
- Metabolic disease
- Chronic kidney or liver failure
- Shock
- Contraindications for lipid administration
- PN during the 15 days before hospitalisation
Trial locations and contacts
1 site in 1 country.
China1 site
Sir Run Run Shaw Hosptial
Hangzhou, Zhejiang, 310016
Wei Zhou, +86-13588706479, nuzwlvran@yahoo.com.cn
About this study
Official title: Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery
The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.
Read the detailed description
Postoperative patients are randomized by a sealed envelope to receive either a 50:50 (vol/vol) mixture of an oil rich in medium-chain fatty acids and soybean oil (termed MCT/LCT) or a mixture of MCT/LCT and fish oil Omegaven for 7 days. Full blood count, biochemistry and coagulation are routinely assessed. Fresh blood samples are centrifuged into plasma, red blood cells and lymphocytes then stored at -80°C pending analysis.
The primary endpoint was numbers of infective complications.Secondary endpoints were other clinical outcomes, length of hospital stay, and in-hospital mortality, along with plasma immunological markers.
- Conditions
- Gastric Tumor, Pancreatic Tumor, Liver Tumor
- Being tested
- MCT/LCT and fish oil, MCT/LCT
- Medical subject headings
- Stomach Neoplasms, Pancreatic Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCT/LCT and fish oilDrug
Also called Structural Fat Emulsion Injection (Fresenius-Kabi, Germany) and fish oil (Omegaven,Fresenius-Kabi, Germany)
MCT/LCTDrug
Also called Structural Fat Emulsion Injection (Fresenius-Kabi, Germany)
| Study group | Role | What they receive |
|---|---|---|
| MCT/LCT | Experimental | Structural Fat Emulsion Injection 250ml per day, for 7 days Receives: Drug: MCT/LCT |
| MCT/LCT and fish oil | Experimental | Structural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days. Receives: Drug: MCT/LCT and fish oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
infective complications
Measured: within the first 30 days after surgery
Secondary outcomes (2)
length of hospital stay
Measured: average of 2 weeks
plasma immunological markers
Measured: from 1 day before surgery to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric TumorStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Zhou, Sir Run Run Shaw Hospital
- Investigators
- Yiping Mou, MD, Study director, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819961
- Sponsor's protocol ID
- Fo-Lap
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 28 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Omega-3 Fatty Acid-supplemented Parenteral Nutrition Versus Standard Parenteral Nutrition in Patients Undergoing Major Laparoscopic Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01819961
- Acronym / sponsor ID
- Fo-Lap
- Conditions
- Gastric Tumor, Pancreatic Tumor, Liver Tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Wei ZhouUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 28 Mar 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.
The aim of this study is to assess the effect of postoperative parenteral fish oil on clinical outcome and immune function after major laparoscopic abdominal surgery.
Detailed description
Postoperative patients are randomized by a sealed envelope to receive either a 50:50 (vol/vol) mixture of an oil rich in medium-chain fatty acids and soybean oil (termed MCT/LCT) or a mixture of MCT/LCT and fish oil Omegaven for 7 days. Full blood count, biochemistry and coagulation are routinely assessed. Fresh blood samples are centrifuged into plasma, red blood cells and lymphocytes then stored at -80°C pending analysis.
The primary endpoint was numbers of infective complications.Secondary endpoints were other clinical outcomes, length of hospital stay, and in-hospital mortality, along with plasma immunological markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCT/LCT | Experimental | Drug: MCT/LCTStructural Fat Emulsion Injection 250ml per day, for 7 days |
| MCT/LCT and fish oil | Experimental | Drug: MCT/LCT and fish oilStructural Fat Emulsion Injection 250ml and fish oil 100ml for 7 days. |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing an elective major laparoscopic abdominal surgery and required at least 5 days of parenteral nutrition
Key exclusion criteria (5 listed)
- Metabolic disease
- Chronic kidney or liver failure
- Shock
- Contraindications for lipid administration
- PN during the 15 days before hospitalisation
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 |
|---|---|---|
| MCT/LCT and fish oilAlso: Structural Fat Emulsion Injection (Fresenius-Kabi, Germany) and fish oil (Omegaven,Fresenius-Kabi, Germany) | Drug | MCT/LCT and fish oil |
| MCT/LCTAlso: Structural Fat Emulsion Injection (Fresenius-Kabi, Germany) | Drug | MCT/LCT |
Primary outcome
infective complications
Time frame: within the first 30 days after surgery
2 secondary outcomes
length of hospital stay
Time frame: average of 2 weeks
plasma immunological markers
Time frame: from 1 day before surgery to 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2013.
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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.
Yiping Mou, MD study director
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MCT/LCT and fish oil and MCT/LCT in people with Gastric Tumor and Pancreatic Tumor, run by Wei Zhou at 1 site in China.
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 1 inclusion and 5 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 28 Mar 2013. 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 China. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Wei Zhou, MD, PhD (+86-13588706479, nuzwlvran@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infective complications (time frame: within the first 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Mar 2013.