Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancrea… (NCT05271344) | Clinical Trial Compass
UnknownNot Applicable
Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.
Belgium74 participantsStarted 2022-04-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Calculation of the Comprehensive Complication Index (CCI)
Timeframe: From the Day of the operation to the patient's discharge Day of the hospital, up to 90 days after surgery