Postoperative Enteral Immunonutrition in Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02647476
• Other study ID #: KBET/91/L/2004
• Status: Completed
• Phase: Phase 3
• Start date: November 2004
• Est. completion date: October 2015

Study information

• Verified date: February 2019
• Source: Jagiellonian University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: October 2015
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Postoperative Complications
• Stomach Neoplasms

Intervention

Dietary Supplement:
• Immunomodulating nutrition (Reconvan)
protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi
• Standard nutrition (Peptisorb)
oligopeptide, low-fat, isocaloric, non-residue diet

Locations

Country	Name	City	State
Poland	1st Department of General Surgery	Kraków	Malopolska

Sponsors (1)

Lead Sponsor	Collaborator
Jagiellonian University

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Scislo L, Pach R, Nowak A, Walewska E, Gadek M, Brandt P, Puto G, Szczepanik AM, Kulig J. The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients - Randomized Clinical Trial. Nutr Cancer. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complication rate	Complication rate during 30 days after the operation	30 days
Secondary	Overall survival	5-year overall survival	5 years

External Links

•   LInk to full text of the article with results summary