Pilot, Randomized, Double-blind Trial To Study The Effect Of Parenteral Supplementation With Fish Oil Emulsion In The Nutritional Support Of Esophagectomized Patients

Background Esophagectomy is a major surgical procedure with a high degree of catabolic and postsurgical inflammatory response that conditions a high morbidity and a significant mortality. Enteral administration of ω-3 fatty acids has been seen to be effective although its use is limited due to tolerance. There are few clinical trials with ω-3 fatty acids parenterally in these patients, so we propose to investigate the effect of combining a lipid emulsion rich in fish oil with the standard enteral nutrition support. Methods Prospective, single-center, randomized, double-blind study in patients diagnosed with esophageal cancer and after esophagectomy treated with a lipid emulsion rich in ω-3 fatty acid emulsion or a mixture of ω-6 long chain triglycerides (LCT) / short chain triglycerides (MCT) 50%. After surgery, these emulsions will be added to the standard nutritional support in continuous infusion until complete 5 days of treatment. Patients will be randomized 1:1:1 in Group A 0,4g/kg/day of lipid emulsion rich in fish oil; Group B 0,8g/kg/day of lipid emulsion rich in fish oil and Group C 0,8g/kg/day of LCT/MCT emulsion. The main objective is to determine whether the administration for 5 days of intravenous lipid emulsions rich in ω-3 fatty acids in patients after esophagectomy is effective in normalizing the interleukin-6 (IL6) compared with LCT/MCT emulsions, and if 0,8 g/kg/day dose is more effective than 0,4g/kg/day. Secondary outcomes include other inflammatory markers as C reactive protein (CRP), tumor necrosis factor alpha (TNF-a) and interleukin-10 (IL-10), and parameters of morbidity, safety, nutrition and mortality. Samples will be collected at the moment of surgery indication and on days 0, 1, 3, 5 and 21 to determine inflammatory, nutritional, hepatic and security parameters. In addition, clinical follow-up throughout the hospital stay and up to one year after surgery. Discussion There are few studies of fatty acids ω-3 administered via parenteral in oesophagectomized patients. This study proposes to investigate the effect of combining fish-oil lipid emulsions administered via parenteral with enteral nutrition support, implying benefits such as: fast incorporation of lipids to the cellular membranes and to the inflammatory cascade, and the use of only one pharmaconutrient.