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Sponsored by: |
Jagiellonian University |
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Information provided by: | Jagiellonian University |
ClinicalTrials.gov Identifier: | NCT00558155 |
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.
Condition | Intervention | Phase |
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Gastric Cancer Pancreatic Cancer |
Drug: peptisorb Drug: Stresson Drug: Parenteral nutrition Drug: Omegaven, Dipeptiven |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Title: The Impact of Immunostimulating Nutrition on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial. |
Enrollment: | 214 |
Study Start Date: | June 2001 |
Study Completion Date: | December 2005 |
Arms | Assigned Interventions |
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SEN: Experimental
standard enteral nutrition
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Drug: peptisorb
standard isocaloric eteral diet (1 ml = 1 kcal)
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IMEN: Experimental
immunostimulating enteral nutrition
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Drug: Stresson
Oligopeptic, enteral diet (1 ml=1.25 kcal)
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SPN: Experimental
standard parenteral nutrition
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Drug: Parenteral nutrition
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
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IMPN: Experimental
immunostimulating parenteral nutrition
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Drug: Omegaven, Dipeptiven
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
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Poland | |
1st Department of General Surgery | |
Krakow, Poland, 30-798 |
Principal Investigator: | Stanislaw Klek, PhD, MD | Jagiellonian University 1 Dept Surgery |
Study ID Numbers: | 1st Dept Surg |
Study First Received: | November 9, 2007 |
Last Updated: | November 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00558155 History of Changes |
Health Authority: | Poland: Ministry of Health |
immunonutrition enteral nutrition parenteral nutrition surgery |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Stomach Neoplasms |
Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms Endocrinopathy Stomach Cancer Endocrine Gland Neoplasms |
Neoplasms Stomach Diseases Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Gastrointestinal Diseases |
Pancreatic Neoplasms Stomach Neoplasms Endocrine System Diseases Pancreatic Diseases Gastrointestinal Neoplasms Endocrine Gland Neoplasms |