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2022-04-08
2025-09
2026-03
74
NCT05271344
Centre Hospitalier Universitaire de Liege
Centre Hospitalier Universitaire de Liege
INTERVENTIONAL
Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-01-26 | N/A | 2023-09-08 |
2022-03-04 | N/A | 2023-09-11 |
2022-03-09 | N/A | 2023-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Prevention
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Triple
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| PLACEBO_COMPARATOR: Placebo Group Placebo products for probiotics, prebiotics, omega 3 and vitamin D | DIETARY_SUPPLEMENT: Nutritional Products
|
| EXPERIMENTAL: Treated Group 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
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Alain Pans, MD Phone Number: 003243667216 Email: a.pans@chuliege.be |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
