Clinical trial to purchase the effect of supplementation with intravenous fish oil on the evolution of esophagectomized patients

Phase 1

• Conditions: Esophagectomy due to esophageal neoplasia; MedDRA version: 20.0Level: PTClassification code 10067473Term: Immunomodulatory therapySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10044107Term: Total parenteral nutritionSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: LLTClassification code 10015460Term: EsophagectomySystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10024587Term: LipidsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2016-004978-17-ES
• Lead Sponsor: Hospital Universitari Bellvitge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-31
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified