Clinical trial · Interventional
The Impact of Immunostimulating Nutrition on the Outcome of Surgery
Title: The Impact of Immunostimulating Nutrition on Infectious Complications After Upper Gastrointestinal Surgery - A Prospective, Randomized, Clinical Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205 subjects were randomly assigned into four study groups, standard and immunostimulating, enteral and parenteral. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omegaven, Dipeptiven | Drug | — | UNRESOLVED |
| Parenteral nutrition | Drug | — | UNRESOLVED |
| peptisorb | Drug | — | UNRESOLVED |
| Stresson | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- SEN
- description
- standard enteral nutrition
- interventionNames
- Drug: peptisorb
- type
- EXPERIMENTAL
- label
- IMEN
- description
- immunostimulating enteral nutrition
- interventionNames
- Drug: Stresson
- type
- EXPERIMENTAL
- label
- SPN
- description
- standard parenteral nutrition
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * resectable gastric or pancreatic cancer * age between 18 and 80 years, * Karnofsky performance status score of 80 or more, * adequate organ function Exclusion Criteria: * unresectable gastric or pancreatic cancer * patients requiring preoperative nutritional support, * disseminated tumors, * serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), * renal or liver failure were excluded
References
Publications (2)
- DERIVEDKlek S, Sierzega M, Szybinski P, Szczepanek K, Scislo L, Walewska E, Kulig J. Perioperative nutrition in malnourished surgical cancer patients - a prospective, randomized, controlled clinical trial. Clin Nutr. 2011 Dec;30(6):708-13. doi: 10.1016/j.clnu.2011.07.007. Epub 2011 Aug 5. PMID 21820770
- DERIVEDKlek S, Kulig J, Sierzega M, Szybinski P, Szczepanek K, Kubisz A, Kowalczyk T, Gach T, Pach R, Szczepanik AM. The impact of immunostimulating nutrition on infectious complications after upper gastrointestinal surgery: a prospective, randomized, clinical trial. Ann Surg. 2008 Aug;248(2):212-20. doi: 10.1097/SLA.0b013e318180a3c1. PMID 18650630