Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.

Pancreatic Cancer Clinical Trial

— SIO3D  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05271344
• Other study ID #: SIO3D
• Status: Recruiting
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: March 2026

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire de Liege
• Contact: Alain Pans, MD
• Phone: 003243667216
• Email: a.pans[@]chuliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: March 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication,Postoperative
• Pancreatic Cancer
• Postoperative Complications
• Surgery

Intervention

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

Locations

Country	Name	City	State
Belgium	CHU	Liège

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Liege

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Jablonska B, Mrowiec S. The Role of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy. Nutrients. 2020 Aug 23;12(9):2547. doi: 10.3390/nu12092547. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Research of occult-bacterial translocation in blood samples	q-PCR technique	Day+1 and Day+4 postoperative day
Secondary	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
Secondary	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