Pancreatic CancerSIO3DNCT05271344
Oral Immunonutrition With Synbiotics, Omega 3 and Vitamin D in Patients Undergoing Duodenopancreatectomy for Tumoral Lesion.
A study testing Nutritional Products in people with Pancreatic Cancer and Complication,Postoperative, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Complication,Postoperative, Surgery
- What is being tested?
- Nutritional Products
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Apr 2022to Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All cases of duodenopancreatectomy for tumoral lesions.
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU
Liège, 4000
Alain Pans, MD, 003243667216, a.pans@chuliege.be
About this study
Official title: 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.
Read the 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.
- Conditions
- Pancreatic Cancer, Complication,Postoperative, Surgery
- Being tested
- Nutritional Products
- Keywords
- synbiotics, omega 3, vitamin D, probiotics, prebiotics
- Medical subject headings
- Pancreatic Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional ProductsDietary supplement
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
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | Placebo products for probiotics, prebiotics, omega 3 and vitamin D Receives: Dietary Supplement: Nutritional Products |
| Treated Group | Experimental | 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. Receives: Dietary Supplement: Nutritional Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the Day of the operation to the patient's discharge Day of the hospital, up to 90 days after surgery
Secondary outcomes (4)
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, ...
Measured: up to 90 days after surgery
Research of occult-bacterial translocation in blood samples
q-PCR technique
Measured: Day+1 and Day+4 postoperative day
Metagenomic characterization of the faecal microbiota
Metagenomic sequencing through faecal samples
Measured: 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
Measured: Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and the day of the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start8 Apr 2022
- Primary completionSep 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alain Pans, Centre Hospitalier Universitaire de Liege
- Investigators
- Arnaud De Roover, Pr, Study director, Centre Hospitalier Universitaire de LiegeAlain Pans, MD, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271344
- Sponsor's protocol ID
- SIO3D
- Acronym
- SIO3D
- Status last verified
- Sep 2023
- First submitted
- 26 Jan 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jablonska B, Mrowiec S. The Role of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy. Nutrients. 2020 Aug 23;12(9):2547. doi: 10.3390/nu12092547.
PubMed 32842475
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05271344
- Acronym / sponsor ID
- SIO3D / SIO3D
- Conditions
- Pancreatic Cancer, Complication,Postoperative, Surgery
- Keywords
- synbiotics, omega 3, vitamin D, probiotics, prebiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Dietary Supplement: Nutritional ProductsPlacebo products for probiotics, prebiotics, omega 3 and vitamin D |
| Treated Group | Experimental | Dietary Supplement: Nutritional ProductsOmega 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All cases of duodenopancreatectomy for tumoral lesions.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional ProductsOmega 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 | Dietary supplement | Placebo Group, Treated Group |
Primary outcome
Calculation of the Comprehensive Complication Index (CCI)
Time frame: 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.
4 secondary outcomes
Rate of infectious or non infectious complications and rate of mortality
Time frame: up to 90 days after surgery
Research of occult-bacterial translocation in blood samples
Time frame: Day+1 and Day+4 postoperative day
Metagenomic characterization of the faecal microbiota
Time frame: Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and Day-1 preoperative day
Blood determination of lipopolysaccharide binding protein
Time frame: Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and the day of the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 32842475Jablonska B, Mrowiec S. The Role of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy. Nutrients. 2020 Aug 23;12(9):2547. doi: 10.3390/nu12092547.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud De Roover, Pr study director
Centre Hospitalier Universitaire de Liege
Alain Pans, MD principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional Products in people with Pancreatic Cancer and Complication,Postoperative, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain Pans, MD (003243667216, a.pans@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of the Comprehensive Complication Index (CCI) (time frame: From the Day of the operation to the patient's discharge Day of the hospital, up to 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05271344, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.