The Impact of Immunostimulating Nutrition on the Outcome of Surgery
Condition: Gastric Cancer; Pancreatic Cancer
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was to assess the clinical effect of immunostimulatory enteral and
      parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205
      subjects were randomly assigned into four study groups, standard and immunostimulating,
      enteral and parenteral. The study was designed to test the hypothesis that immunonutrition
      and enteral nutrition would reduce the incidence of infectious complications following upper
      gastrointestinal surgery.
    

Detailed description: 
      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.
    

Intervention name(s): peptisorb; Stresson; Parenteral nutrition; Omegaven, Dipeptiven
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): standard isocaloric eteral diet (1 ml = 1 kcal); Oligopeptic, enteral diet (1 ml=1.25 kcal); Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel; Immunostimulating components: Omegaven (omega-3-fatty acids) and Dipeptiven (Glutamine Arginine) Protein requirements were covered by 10 and 15% amino acid solutions (Aminoplasmal, B Braun, Poland). Energy requirements were covered by glucose (10, 20 and 40% solutions, B Braun, Poland) and lipid emulsions (10 and 20% Lipofundin MCT/ LCT, B Braun, Poland). Addtional: Tracutil, Addamel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunonutrition; enteral nutrition; parenteral nutrition; surgery