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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Placebo products for probiotics, prebiotics, omega 3 and vitamin D |
|
| Treated Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Products | Dietary Supplement | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alain Pans, MD | Contact | 003243667216 | a.pans@chuliege.be |
| Name | Affiliation | Role |
|---|---|---|
| Arnaud De Roover, Pr | Centre Hospitalier Universitaire de Liege | Study Director |
| Alain Pans, MD | Centre Hospitalier Universitaire de Liege | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Recruiting | Liège | 4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32842475 | Background | Jablonska B, Mrowiec S. The Role of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy. Nutrients. 2020 Aug 23;12(9):2547. doi: 10.3390/nu12092547. |
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| 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 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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