The Impact of Immunostimulating Nutrition on the Outcome of Surgery

NCT ID: NCT00558155

Last Updated: 2007-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-06-30
• Study Completion Date: 2005-12-31

Brief 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.

Conditions

Gastric Cancer; Pancreatic Cancer

Keywords

immunonutrition; enteral nutrition; parenteral nutrition; surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SEN

standard enteral nutrition

Group Type: EXPERIMENTAL

peptisorb

Intervention Type: DRUG

standard isocaloric eteral diet (1 ml = 1 kcal)

IMEN

immunostimulating enteral nutrition

Group Type: EXPERIMENTAL

Stresson

Intervention Type: DRUG

Oligopeptic, enteral diet (1 ml=1.25 kcal)

SPN

standard parenteral nutrition

Group Type: EXPERIMENTAL

Parenteral nutrition

Intervention Type: DRUG

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

IMPN

immunostimulating parenteral nutrition

Group Type: EXPERIMENTAL

Omegaven, Dipeptiven

Intervention Type: DRUG

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

Interventions

peptisorb

standard isocaloric eteral diet (1 ml = 1 kcal)

Intervention Type: DRUG

Stresson

Oligopeptic, enteral diet (1 ml=1.25 kcal)

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Principal Investigators

Stanislaw Klek, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University 1 Dept Surgery

Locations

1st Department of General Surgery

Krakow, , Poland

Countries

Poland

References

Klek S, Sierzega M, Szybinski P, Szczepanek K, Scislo L, Walewska E, Kulig J. Perioperative nutrition in malnourished surgical cancer patients - a prospective, randomized, controlled clinical trial. Clin Nutr. 2011 Dec;30(6):708-13. doi: 10.1016/j.clnu.2011.07.007. Epub 2011 Aug 5.

Reference Type: DERIVED

PMID: 21820770 (View on PubMed)

Klek S, Kulig J, Sierzega M, Szybinski P, Szczepanek K, Kubisz A, Kowalczyk T, Gach T, Pach R, Szczepanik AM. The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial. Ann Surg. 2008 Aug;248(2):212-20. doi: 10.1097/SLA.0b013e318180a3c1.

Reference Type: DERIVED

PMID: 18650630 (View on PubMed)

Other Identifiers

1st Dept Surg

Identifier Type: -

Identifier Source: org_study_id