Clinical trial · Interventional
Standard and Immunostimulating Enteral Nutrition in Surgical Patients
Standard and Immunostimulating Enteral Nutrition in Patients After Extended Gastrointestinal Surgery - A Prospective, Randomized, Controlled Clinical Trial
NCT00576940CI-TRIAL-00001033ImmuniEteralcompletedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 immunomodulating enteral nutrition in patients undergoing resection for gastrointestinal cancer. 196 subjects were randomly assigned into two study groups: standard and immunostimulating. The study failed to demonstrate any clear advantage of routine postoperative immunonutrition in patients undergoing elective 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peptisorb | Drug | — | UNRESOLVED |
| Reconvan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- IMEN: 1
- description
- Enteral nutrition with immunostimulating diet (IMEN group: formula supplemented with arginine, glutamine, omega-3 fatty acids)
- interventionNames
- Drug: Reconvan
- type
- ACTIVE_COMPARATOR
- label
- SEN
- description
- postoperative enteral nutrition - standard oligopeptic diet
- interventionNames
- Drug: Peptisorb
Primary outcomes (1)
- measure
- The ratio of postoperative complications (infectious and surgical)
- timeFrame
- Postoperative complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged 18-80 years undergoing subtotal and total gastric resection with lymphadenectomy and pancreatoduodenectomy/ total pancreatectomy with lymphadenectomy, in good general status (Karnofsky \> 80, Eastern Cooperative Oncology Group (ECOG) grade 0 or 1); with no confirmed neoplastic dissemination nor distant metastases * No severe concomitant disease (heart failure, chronic obstructive pulmonary disease \[COPD\], coronary aortic bypass graft \[CABG\], etc.) * No history of known allergies or drug intolerance Exclusion Criteria: * Patients with metastatic or unresectable disease * Pregnant * In poor general status (Karnofsky \<80, Eastern Cooperative Oncology Group (ECOG) \> 1) * With recent history of severe heart, lung, kidney or liver failure * With history of allergies or drug intolerance
References
Publications (4)
- RESULTBraga M, Gianotti L, Nespoli L, Radaelli G, Di Carlo V. Nutritional approach in malnourished surgical patients: a prospective randomized study. Arch Surg. 2002 Feb;137(2):174-80. doi: 10.1001/archsurg.137.2.174. PMID 11822956
- DERIVEDKlek S, Szybinski P, Szczepanek K. Perioperative immunonutrition in surgical cancer patients: a summary of a decade of research. World J Surg. 2014 Apr;38(4):803-12. doi: 10.1007/s00268-013-2323-z. PMID 24178185
- DERIVEDKlek S, Sierzega M, Szybinski P, Szczepanek K, Scislo L, Walewska E, Kulig J. The immunomodulating enteral nutrition in malnourished surgical patients - a prospective, randomized, double-blind clinical trial. Clin Nutr. 2011 Jun;30(3):282-8. doi: 10.1016/j.clnu.2010.10.001. Epub 2010 Nov 13. PMID 21074910
- DERIVEDKlek S, Kulig J, Sierzega M, Szczepanek K, Szybinski P, Scislo L, Walewska E, Kubisz A, Szczepanik AM. Standard and immunomodulating enteral nutrition in patients after extended gastrointestinal surgery--a prospective, randomized, controlled clinical trial. Clin Nutr. 2008 Aug;27(4):504-12. doi: 10.1016/j.clnu.2008.04.010. Epub 2008 Jun 20. PMID 18571296