Postoperative Enteral Immunonutrition in Gastric Cancer

Phase 3

Completed

• Conditions: Gastric Cancer
• Interventions: Dietary Supplement: Immunomodulating nutrition (Reconvan); Dietary Supplement: Standard nutrition (Peptisorb)

• Registration Number: NCT02647476
• Lead Sponsor: Jagiellonian University

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.

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2010-12
• Study Completion: 2015-10
• Study First Submitted: 2016-01-01
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-06
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Immunomodulating nutrition (Reconvan)	Immunomodulating nutrition (Reconvan)
Control group	Standard nutrition (Peptisorb)	Standard nutrition (Peptisorb)

Primary Outcome Measures

Name	Time	Method
Postoperative complication rate	30 days	Complication rate during 30 days after the operation

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	5-year overall survival

Trial Locations

Locations (1)

1st Department of General Surgery; 🇵🇱 Kraków, Malopolska, Poland