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OpenTrials
Completed

NCT Number: NCT02647476

Postoperative Enteral Immunonutrition in Gastric Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

1st Department of General Surgery

Krakow, Malopolska, 31-501, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunomodulating nutrition (Reconvan)

Dietary Supplement

protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi

Standard nutrition (Peptisorb)

Dietary Supplement

oligopeptide, low-fat, isocaloric, non-residue diet

Primary outcomes

  1. Postoperative complication rate

    Time frame: 30 days

    Complication rate during 30 days after the operation

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

    5-year overall survival

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2010
Study completion
2015
First posted
Jan 6, 2016
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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