The Impact of Immunostimulating Nutrition on the Outcome of Surgery

This study has been completed.
Sponsor:
Information provided by:
Jagiellonian University
ClinicalTrials.gov Identifier:
NCT00558155
First received: November 9, 2007
Last updated: November 13, 2007
Last verified: November 2007
  Purpose

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
Gastric Cancer
Pancreatic Cancer
Drug: peptisorb
Drug: Stresson
Drug: Parenteral nutrition
Drug: Omegaven, Dipeptiven
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Title: The Impact of Immunostimulating Nutrition on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Jagiellonian University:

Primary Outcome Measures:
  • During the postoperative period, all patients were observed for both surgical and non-surgical complications [ Time Frame: 52 months ]

Secondary Outcome Measures:
  • The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and hospital stay. [ Time Frame: 52 months ]

Enrollment: 214
Study Start Date: June 2001
Study Completion Date: December 2005
Arms Assigned Interventions
Experimental: SEN
standard enteral nutrition
Drug: peptisorb
standard isocaloric eteral diet (1 ml = 1 kcal)
Experimental: IMEN
immunostimulating enteral nutrition
Drug: Stresson
Oligopeptic, enteral diet (1 ml=1.25 kcal)
Experimental: SPN
standard parenteral nutrition
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
Experimental: IMPN
immunostimulating parenteral nutrition
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00558155

Locations
Poland
1st Department of General Surgery
Krakow, Poland, 30-798
Sponsors and Collaborators
Jagiellonian University
Investigators
Principal Investigator: Stanislaw Klek, PhD, MD Jagiellonian University 1 Dept Surgery
  More Information

No publications provided by Jagiellonian University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00558155     History of Changes
Other Study ID Numbers: 1st Dept Surg
Study First Received: November 9, 2007
Last Updated: November 13, 2007
Health Authority: Poland: Ministry of Health

Keywords provided by Jagiellonian University:
immunonutrition
enteral nutrition
parenteral nutrition
surgery

Additional relevant MeSH terms:
Pancreatic Neoplasms
Stomach Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Gastrointestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on September 18, 2014