An interventional study of Nutritional Products in Pancreatic Cancer, Complication,Postoperative and Surgery, sponsored by Centre Hospitalier Universitaire de Liege. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Centre Hospitalier Universitaire de Liege · Not applicable, Interventional, and Prevention
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.
1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.
This study's planned enrollment of 74 is below the median of 119 across 689 interventional studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Centre Hospitalier Universitaire de Liege is the lead sponsor of 37 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo products for probiotics, prebiotics, omega 3 and vitamin D
Dietary Supplement: Nutritional Products
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
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
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.
Time frame: From the Day of the operation to the patient's discharge Day of the hospital, up to 90 days after surgery
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, ...
Time frame: up to 90 days after surgery
Research of occult-bacterial translocation in blood samples
q-PCR technique
Time frame: Day+1 and Day+4 postoperative day
Metagenomic characterization of the faecal microbiota
Metagenomic sequencing through faecal samples
Time frame: 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
Time frame: Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and the day of the operation
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Centre Hospitalier Universitaire de Liege