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

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer; Surgery; Complication,Postoperative
• Interventions: Dietary Supplement: Nutritional Products

• Registration Number: NCT05271344
• Lead Sponsor: Centre Hospitalier Universitaire de Liege

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.

Study Timeline

• Study First Submitted: 2022-01-26
• Study First Submitted QC: 2022-03-04
• Study First Posted: 2022-03-09
• Study Start: 2022-04-08
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-08
• Last Update Posted: 2023-09-11
• Primary Completion: 2025-09
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Nutritional Products	Placebo products for probiotics, prebiotics, omega 3 and vitamin D
Treated Group	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.

Primary Outcome Measures

Name	Time	Method
Calculation of the Comprehensive Complication Index (CCI)	From the Day of the operation to the patient's discharge Day of the hospital, up to 90 days after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Rate of infectious or non infectious complications and rate of mortality	up to 90 days after surgery	Wound infection, pulmonary infection, urinary infection, intra-abdominal abscess, sepsis, pancreatic fistula, delayed gastric emptying, wound dehiscence, intestinal obstruction, intra-abdominal bleeding, pulmonary embolism, ...
Metagenomic characterization of the faecal microbiota	Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and Day-1 preoperative day	Metagenomic sequencing through faecal samples
Blood determination of lipopolysaccharide binding protein	Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and the day of the operation	As a measure of intestinal barrier integrity
Research of occult-bacterial translocation in blood samples	Day+1 and Day+4 postoperative day	q-PCR technique

Trial Locations

Locations (1)

CHU; 🇧🇪 Liège, Belgium