Postoperative Enteral Immunonutrition in Gastric Cancer
The Impact of Postoperative Enteral Immunonutrition on Postoperative Complications and Survival in Gastric Cancer Patients
1 other identifier
interventional
98
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 gastric-cancer
Started Nov 2004
Longer than P75 for phase_3 gastric-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 1, 2016
CompletedFirst Posted
Study publicly available on registry
January 6, 2016
CompletedFebruary 27, 2019
February 1, 2019
6.1 years
January 1, 2016
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative complication rate
Complication rate during 30 days after the operation
30 days
Secondary Outcomes (1)
Overall survival
5 years
Study Arms (2)
Study group
EXPERIMENTALImmunomodulating nutrition (Reconvan)
Control group
ACTIVE COMPARATORStandard nutrition (Peptisorb)
Interventions
protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi
oligopeptide, low-fat, isocaloric, non-residue diet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- severe malnutrition which required parenteral nutrition
- urgent operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1st Department of General Surgery
Krakow, Malopolska, 31-501, Poland
Related 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. 2018 Apr;70(3):453-459. doi: 10.1080/01635581.2018.1445770. Epub 2018 Mar 13.
PMID: 29533110RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Radosław Pach, MD PhD
1st Dept. of General Surgery, Jagiellonian University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant Professor
Study Record Dates
First Submitted
January 1, 2016
First Posted
January 6, 2016
Study Start
November 1, 2004
Primary Completion
December 1, 2010
Study Completion
October 1, 2015
Last Updated
February 27, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share