Trial Information

Title: The Impact of Immunostimulating Nutrition on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.

All patients qualified between June 2001 and December 2005 to total and distal subtotal
gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the
study. Additional eligibility criteria included: age between 18 and 80 years, Karnofsky
performance status score of 80 or more, and adequate organ function measured by routine
blood tests. Patients requiring preoperative nutritional support, as well as those with
disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class
of 4 or 5), and renal or liver failure were excluded. The study was designed to test the
hypothesis that immunonutrition and enteral nutrition would reduce the incidence of
infectious complications following upper gastrointestinal surgery. Therefore, patients were
randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating
versus normal diets, and enteral versus intravenous nutritional support. The secondary
objective of the study was to evaluate the effect of nutritional intervention on overall
morbidity and mortality rates, and the length of hospital stay.

After completing tumor resection, patients who met the eligibility criteria were
intraoperatively assigned to either of the treatment groups using sealed envelopes
containing computer-generated allocation numbers. The following groups were generated:
standard enteral nutrition (SEN), immunostimulating enteral nutrition (IMEN), standard
parenteral nutrition (SPN), and immunostimulating parenteral nutrition (IMPN). The study was
carried out following the international ethical recommendations stated in the Declaration of
Helsinki.