The Impact of Immunostimulating Nutrition on the Outcome of Surgery

Phase 4

Completed

• Conditions: Gastric Cancer; Pancreatic Cancer
• Interventions: Drug: peptisorb; Drug: Stresson; Drug: Parenteral nutrition; Drug: Omegaven, Dipeptiven

• Registration Number: NCT00558155
• Lead Sponsor: Jagiellonian University

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.

Study Timeline

• Study Start: 2001-06
• Study Completion: 2005-12
• Status Verified: 2007-11
• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-13
• Last Update Submitted: 2007-11-13
• Study First Posted: 2007-11-14
• Last Update Posted: 2007-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SEN	peptisorb	standard enteral nutrition
IMEN	Stresson	immunostimulating enteral nutrition
SPN	Parenteral nutrition	standard parenteral nutrition
IMPN	Omegaven, Dipeptiven	immunostimulating parenteral nutrition

Primary Outcome Measures

Name	Time	Method
During the postoperative period, all patients were observed for both surgical and non-surgical complications	52 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

1st Department of General Surgery; 🇵🇱 Krakow, Poland