Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion. (SIO3D)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Surgery; Complication,Postoperative
• Intervention / Treatment: Dietary supplement: Nutritional Products

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.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alain Pans, MD; Phone Number: 003243667216; Email: a.pans@chuliege.be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • CHU
    • Contact: Alain Pans, MD; Phone Number: 003243667216; Email: a.pans@chuliege.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

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; 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
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Liege
• Investigators: Study Director: Arnaud De Roover, Pr, Centre Hospitalier Universitaire de Liege; Principal Investigator: Alain Pans, MD, Centre Hospitalier Universitaire de Liege

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: probiotics; omega 3; vitamin D; prebiotics; synbiotics
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: SIO3D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No