Efficacy of a new immunonutrition formula with extra virgin olive oil in the reduction of complications in surgeries of upper digestive tract tumors.

Background: To demonstrate whether a nutritional supplement enriched with arginine, nucleotides, omega-3 fatty acids, and extra virgin olive oil reduces postoperative complications in patients with tumors in the upper digestive tract. Methods: A randomized, controlled, double-blind, multicenter clinical trial, in which a new immunomodulatory formula with extra virgin olive oil was compared with a standard isoprotein and isoenergetic formula. Patients with gastric, esophageal or biliopancreatic tumors were recruited to receive two units of immunomodulatory formula or control, 5 days before the surgical intervention. Results: A total of 119 patients were recruited. There was a significant reduction in the number of reinterventions (7.7 vs. 20.4%; p = 0.044) in the intervention group. There was a significant reduction in the development of fistulas in patients with phase angles >5.7°. Also, there were fewer readmissions after biliopancreatic surgeries (0.0 vs. 100%; p = 0.014). The length of hospital stay was similar between groups; however, with the immunomodulatory formula, the patients exhibited greater phase angle at the end of follow-up. Conclusion: The immunomodulatory formula with extra virgin olive oil administered 5 days before surgery for stomach, esophageal and biliopancreatic tumors improved cellular health and reduced postoperative complications.Clinical trial registration: [https://clinicaltrials.gov/], identifier [NCT04027088].