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

University Hospital Center (CHU) of Liege

Status: Enrolling

Conditions: Surgery; Complication,Postoperative; Pancreatic Cancer

Treatments: Dietary Supplement: Nutritional Products

Study type: Interventional

Funder types: Other

Identifiers

NCT05271344

SIO3D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups, including a placebo group

Placebo Group

Placebo Comparator group

Description:

Placebo products for probiotics, prebiotics, omega 3 and vitamin D

Treatment:

Dietary Supplement: Nutritional Products

Treated Group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nutritional Products