The Impact of Immunostimulating Nutrition on the Outcome of Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Cancer, Pancreatic Cancer

Intervention / Treatment
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* Drug: peptisorb
* Drug: Stresson
* Drug: Parenteral nutrition
* Drug: Omegaven, Dipeptiven


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: resectable gastric or pancreatic cancer age between 18 and 80 years, Karnofsky performance status score of 80 or more, adequate organ function Exclusion Criteria: unresectable gastric or pancreatic cancer patients requiring preoperative nutritional support, disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), renal or liver failure were excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEN<br>standard enteral nutrition | Drug: peptisorb<br>* standard isocaloric eteral diet (1 ml = 1 kcal)<br>|
| Experimental: IMEN<br>immunostimulating enteral nutrition | Drug: Stresson<br>* Oligopeptic, enteral diet (1 ml=1.25 kcal)<br>|
| Experimental: SPN<br>standard parenteral nutrition | Drug: Parenteral nutrition<br>* 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<br>|
| Experimental: IMPN<br>immunostimulating parenteral nutrition | Drug: Omegaven, Dipeptiven<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| During the postoperative period, all patients were observed for both surgical and non-surgical complications |  | 52 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay. |  | 52 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunonutrition, enteral nutrition, parenteral nutrition, surgery