Esophagectomy due to esophageal neoplasia MedDRA version: 20.0 Level: PT Classification code 10067473 Term: Immunomodulatory therapy System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10044107 Term: Total parenteral nutrition System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10015460 Term: Esophagectomy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Omegaven
Fish oil intravenous emulsion
Product Name: Omegaven
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: Eicosapentanoic acid
CAS Number: 25378-27-2
Current Sponsor c
Sponsors
Hospital Universitari Bellvitge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with esophageal cancer who underwent an esophagectomy using Ivor-Lewis or MacEwan techniques, who meet ALL criteria for inclusion, will be included in the study: 1. Minimum age of 18, of both sexes and of any race / ethnicity. 2. Willing to give their IC in writing for the trial and be able to do so. If a subject can not independently give their IC in writing, they can do so by their legal representative in their place. 3. With a pathway to the digestive tract Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria will not be included in the study: 1. Have a history of type I hypersensitivity or idiosyncratic reactions to any component of intravenous lipid emulsions. 2. Pregnant or lactating women 3. Have plasma triglycerides> 3 mmol / L 4. Treated with chronic steroids or immunosuppressants in the previous month. 5. Have AIDS or be transplanted. 6. Hepatic dysfunction: with Child-Pugh grade B (significant functional compromise) and grade C (decompensated disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to determine whether, in esophagectomized patients, the administration of 5 days of fish oil intravenous lipid emulsions normalized the intraleukin-6 (IL-6). To determine whether 5-day administration of endovenous lipid emulsions derived from fish oil in esophagectomized patients at a dose of 0.8 g / kg / day is more effective than a dose at 0.4 g / kg / day in reducing the Inflammation expressed in terms of serum concentration of Interleukin-6.;Secondary Objective: Secondary objectives include the study of other inflammatory markers (C-reactive protein, alpha tumor necrosis factor, IL-10, IL-8 and soluble CD25), morbidity, safety, nutrition, and mortality parameters.;Primary end point(s): Interleukin-6 will be determined as the main variable.;Timepoint(s) of evaluation of this end point: Blood samples will be collected on days 0, 1, 3, 5 and 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): We will determine others inflammatory parameters (C-reactive Protein, Tumor Necrosis Factor alpha, IL-10, IL-8 and soluble CD25), nutritional, hepatic and Safety (INR, platelets).;Timepoint(s) of evaluation of this end point: Blood samples will be collected on days 0, 1, 3, 5 and 21 Mortality will be determined one year after inclusion in the study | — |
Countries
Spain
Contacts
Public ContactPharmacy Department
Hospital Universitari Bellvitge
Outcome results
None listed