Gastric Cancer Clinical Trial
Official title:
Multicenter Randomized Clinical Trial of the Effect of Preoperative Immunonutrition Versus Standard Enteral Nutrition in Elective Oncological Surgery of the Upper Digestive Tract
Randomized, double-blind, multicenter clinical trial that will evaluate the effects of immuno-nutrition in the preoperative period in patients with cancer of the upper digestive tract (esophagus, stomach, and pancreas). The aim is to compare the specific effect of the immunonutrients respect to an equivalent formula in caloric-protein value but without immunonutrients, in the surgical evolution of the cancer patient.
Status | Recruiting |
Enrollment | 178 |
Est. completion date | December 31, 2021 |
Est. primary completion date | August 10, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of cancer of esophagus, stomach and / or pancreas, at any stage, proposed for surgery - Signing informed consent Exclusion Criteria: - Pregnant or breastfeeding - Advanced renal insufficiency prior to dialysis (GFR <25 ml / min) - Allergy or intolerance to any of the components of the dietary supplement (including fish allergy) - Patients with contraindications for enteral nutrition |
Country | Name | City | State |
---|---|---|---|
Spain | Alfonso Vidal-Casariego | A Coruña | La Coruna |
Spain | Miguel A. Martínez Olmos | Santiago De Compostela | A Coruña |
Lead Sponsor | Collaborator |
---|---|
Complexo Hospitalario Universitario de A Coruña |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infectious complications | Up to 30 days post-operative | ||
Primary | Surgical fistulas | Up to 30 days post-operative | ||
Secondary | Mortality | Up to 30 days post-operative | ||
Secondary | Length of hospital stay | Up to 30 days post-operative | ||
Secondary | Weight loss | 10 days Pre-operative |
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