CLINICAL, RANDOMIZED, DOUBLE LIND CLINICAL TRIAL TO STUDY THE EFFECT OF PARENTERAL SUPPLEMENTATION WITH FISH OIL EMULSION IN THE NUTRITIONAL SUPPORT IN ESOPHAGECTOMIZED PATIENTS - Intravenous fish oil in esophagectomized patients

Hospital Universitari Bellvitge0 个研究点开始时间: 2017年5月31日最近更新: 2017年8月21日

试验速览

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•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

•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).

发起方

Hospital Universitari Bellvitge