Clinical trial NCT02647476: Postoperative Enteral Immunonutrition in Gastric Cancer
Official title: The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: immunonutrition
gastric cancer
enteral nutrition
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Postoperative complication rate
timeFrame: 30 days
Secondary outcomes:
measure: Overall survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: 1st Department of General Surgery
state: Malopolska
Study officials:
affiliation: 1st Dept. of General Surgery, Jagiellonian University
name: Radosław Pach, MD PhD
role: STUDY_CHAIR
References:
citation: 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. 2018 Apr;70(3):453-459. doi: 10.1080/01635581.2018.1445770. Epub 2018 Mar 13.