Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.

Study Overview
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Brief Summary
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The purpose of this trial is to demonstrate that synbioimmunonutrition (SI) combined with omega-3 fatty acids (O3) and Vitamin D (D) is superior to conventional 7-day preoperative immunonutrition in terms of reducing overall morbidity, in cases of duodenopancreatectomy for tumoral lesion.

Detailed Description
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To the best knowledge of the Investigators, a comprehensive multimodal approach to reduce postoperative morbidity in duodenopancreatectomies has not yet been evaluated. In the study, the Investigators combine the main nutritional interventions currently available and already having an individual scientific basis, sequentially and simultaneously, for a potential synergistic effect. In cases of duodenopancreatectomy for tumoral lesion, a group of patients taking only conventional immunonutrition regimen (CIR), for 7 preoperative days, will be compared with a second group where immunonutrition will be maximised by the addition of omega 3 for 1 week prior to the administration of CIR, synbiotics for 14 days pre- and post-operatively, and preoperative vitamin D supplementation for 6 days, in terms of postoperative overall morbidity.

Official Title
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Standard Preoperative Oral Immunonutrition Versus Oral Immunonutrition With Synbiotics, Sustained Omega 3 Impregnation and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion : a Prospective, Placebo-controlled, Double-blind, Randomized Clinical Trial. The SIO3D Study.

Conditions
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Pancreatic Cancer, Complication,Postoperative, Surgery

Intervention / Treatment
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* Dietary Supplement: Nutritional Products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All cases of duodenopancreatectomy for tumoral lesions. Exclusion Criteria: Distal or total pancreatectomies, as well as procedures for chronic pancreatitis Patient refusal or inability to provide informed consent Use of dietary supplements containing omega 3, pre- or probiotics within 15 days prior to protocol initiation Severe cardiorespiratory or renal insufficiency HIV Cirrhosis Child-Pugh B-C Inability to feed by mouth Intestinal obstruction Unresectable tumor or metastatic disease on preoperative work-up Cardiac valvular pathology Short bowell syndrome Haemophilia Known allergy or intolerance to fish oil, fish or shellfish, milk, soy or components of the products used BMI < 16kg/m2 Weight loss > 15% in the last 6 months Little or no food in the last 10 days Hypercalcemia Pregnancy, breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Placebo products for probiotics, prebiotics, omega 3 and vitamin D | Dietary Supplement: Nutritional Products<br>* Omega 3 : 1 softgel, 3 x/d Probiotics : 1 caps / d Prebiotics : 1 measuring spoon of powder to be diluted in water, 1x/d Vitamin D : 1 tablet, 2x/d<br>|
| Experimental: Treated Group<br>Omega 3 fatty acids for 7 days (before starting conventional oral immunonutrition supplement), Probiotics for 14 days before and after the operation, Prebiotics for 14 days before and after the operation, Vitamin D for 6 days before the operation. | Dietary Supplement: Nutritional Products<br>* Omega 3 : 1 softgel, 3 x/d Probiotics : 1 caps / d Prebiotics : 1 measuring spoon of powder to be diluted in water, 1x/d Vitamin D : 1 tablet, 2x/d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculation of the Comprehensive Complication Index (CCI) | This criterion takes into account all the complications of a given patient by weighting their relative importance. It varies from 0 to 100. A score of 0 means the absence of complications. A score of 100 is the death. | From the Day of the operation to the patient's discharge Day of the hospital, up to 90 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of infectious or non infectious complications and rate of mortality | Wound infection, pulmonary infection, urinary infection, intra-abdominal abscess, sepsis, pancreatic fistula, delayed gastric emptying, wound dehiscence, intestinal obstruction, intra-abdominal bleeding, pulmonary embolism, ... | up to 90 days after surgery | 
| Research of occult-bacterial translocation in blood samples | q-PCR technique | Day+1 and Day+4 postoperative day | 
| Metagenomic characterization of the faecal microbiota | Metagenomic sequencing through faecal samples | Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and Day-1 preoperative day | 
| Blood determination of lipopolysaccharide binding protein | As a measure of intestinal barrier integrity | Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and the day of the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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synbiotics, omega 3, vitamin D, probiotics, prebiotics