Ana Suárez-Lledó, Elisabet Leiva Badosa, Josep M Llop Talaveron, Monica Fernandez Alvarez, Leandre Farran Teixidor, Monica Miro Martin, Nuria Virgili Casas, Gloria Creus Costas, Jordi Bas Minguet, Elisabet Poyatos Canton, Sergio Navarro Velazquez, and Maria Bella Badía Tahull
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.