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Clinical Trials/NCT02647476
NCT02647476
Completed
Phase 3

The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients

Jagiellonian University1 site in 1 country98 target enrollmentNovember 2004
ConditionsGastric Cancer

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Gastric Cancer
Sponsor
Jagiellonian University
Enrollment
98
Locations
1
Primary Endpoint
Postoperative complication rate
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival.

The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients.

The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 (Reconvan ,Fresenius Kabi), or standard enteral nutrition n=54 (Peptisorb, Nutricia). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Detailed Description

Treatment of gastric cancer often requires major surgery and carries the risk of postoperative complications and fatal outcomes. Mortality rates after gastrectomy due to gastric cancer have been reported as 2-5%, while the incidence of postoperative complications was 10 to over 40%. Immunomodulating enteral nutrition in the perioperative period may reduce postoperative complications in cancer patients. Little is known if this effect translates to the better survival. The aim of study was to assess the impact of postoperative immunomodulating enteral nutrition on postoperative complications and survival of gastric cancer patients. The group of 98 gastric cancer patients were randomly assigned for postoperative immunomodulating enteral nutrition n=44 or standard enteral nutrition n=54. Following the initial randomization, the patients received either standard nutrition (oligopeptide, low-fat, isocaloric, non-residue diet - Peptisorb, Nutricia) or immunomodulating nutrition (protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi). Postoperative complications, mortality, 6-month, 1-year and 5-year survival were analyzed.

Registry
clinicaltrials.gov
Start Date
November 2004
End Date
October 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jagiellonian University
Responsible Party
Principal Investigator
Principal Investigator

Radoslaw Pach, MD, Ph D

Assisstant Professor

Jagiellonian University

Eligibility Criteria

Inclusion Criteria

  • gastric cancer confirmed in histopathological examination
  • elective operation due to gastric cancer
  • informed consent signed
  • age \> 18 years
  • normal nutritional status or mild to moderate malnutrition

Exclusion Criteria

  • severe malnutrition which required parenteral nutrition
  • urgent operation

Outcomes

Primary Outcomes

Postoperative complication rate

Time Frame: 30 days

Complication rate during 30 days after the operation

Secondary Outcomes

  • Overall survival(5 years)

Study Sites (1)

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