Status:
RECRUITING
Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.
Lead Sponsor:
Centre Hospitalier Universitaire de Liege
Conditions:
Pancreatic Cancer
Complication,Postoperative
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
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...
Eligibility Criteria
Inclusion
- All cases of duodenopancreatectomy for tumoral lesions.
Exclusion
- 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
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT05271344
Start Date
April 8 2022
End Date
March 1 2026
Last Update
September 11 2023
Active Locations (1)
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1
CHU
Liège, Belgium, 4000