Clinical trial NCT05271344: Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Complication,Postoperative
Surgery
Keywords: synbiotics
omega 3
vitamin D
probiotics
prebiotics
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Calculation of the Comprehensive Complication Index (CCI)
timeFrame: From the Day of the operation to the patient's discharge Day of the hospital, up to 90 days after surgery
Secondary outcomes:
measure: Rate of infectious or non infectious complications and rate of mortality
timeFrame: up to 90 days after surgery
measure: Research of occult-bacterial translocation in blood samples
timeFrame: Day+1 and Day+4 postoperative day
measure: Metagenomic characterization of the faecal microbiota
timeFrame: Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and Day-1 preoperative day
measure: Blood determination of lipopolysaccharide binding protein
timeFrame: Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and the day of the operation
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU
Study officials:
affiliation: Centre Hospitalier Universitaire de Liege
name: Arnaud De Roover, Pr
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Universitaire de Liege
name: Alain Pans, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jablonska B, Mrowiec S. The Role of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy. Nutrients. 2020 Aug 23;12(9):2547. doi: 10.3390/nu12092547.