Complication,Postoperative, Pancreatic Cancer, Surgery
Conditions
Keywords
synbiotics, omega 3, vitamin D, probiotics, prebiotics
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTNutritional Products
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
Sponsors
Centre Hospitalier Universitaire de Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calculation of the Comprehensive Complication Index (CCI) | From the Day of the operation to the patient's discharge Day of the hospital, up to 90 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of infectious or non infectious complications and rate of mortality | up to 90 days after surgery | Wound infection, pulmonary infection, urinary infection, intra-abdominal abscess, sepsis, pancreatic fistula, delayed gastric emptying, wound dehiscence, intestinal obstruction, intra-abdominal bleeding, pulmonary embolism, ... |
| Research of occult-bacterial translocation in blood samples | Day+1 and Day+4 postoperative day | q-PCR technique |
| Metagenomic characterization of the faecal microbiota | Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and Day-1 preoperative day | Metagenomic sequencing through faecal samples |
| Blood determination of lipopolysaccharide binding protein | Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and the day of the operation | As a measure of intestinal barrier integrity |
Countries
Belgium
Contacts
Primary ContactAlain Pans, MD
Outcome results
None listed