NCT05271344

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for not_applicable pancreatic-cancer

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 8, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

September 11, 2023

Status Verified

September 1, 2023

Enrollment Period

3.4 years

First QC Date

January 26, 2022

Last Update Submit

September 8, 2023

Conditions

Pancreatic CancerComplication,PostoperativeSurgery

Keywords

synbioticsomega 3vitamin Dprobioticsprebiotics

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    up to 90 days after surgery

  • Research of occult-bacterial translocation in blood samples

    Day+1 and Day+4 postoperative day

  • Metagenomic characterization of the faecal microbiota

    Day-19 (or Day-18, or Day-17, or Day-16) preoperative day and Day-1 preoperative day

  • 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

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

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

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.

Dietary Supplement: Nutritional Products

Interventions

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

Placebo GroupTreated Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All cases of duodenopancreatectomy for tumoral lesions.

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Liège, 4000, Belgium

RECRUITING

Related Publications (1)

  • Jablonska B, Mrowiec S. The Role of Immunonutrition in Patients Undergoing Pancreaticoduodenectomy. Nutrients. 2020 Aug 23;12(9):2547. doi: 10.3390/nu12092547.

    PMID: 32842475BACKGROUND

MeSH Terms

Conditions

Pancreatic NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arnaud De Roover, Pr

    Centre Hospitalier Universitaire de Liege

    STUDY DIRECTOR

  • Alain Pans, MD

    Centre Hospitalier Universitaire de Liege

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain Pans, MD

CONTACT

003243667216a.pans@chuliege.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Clinic, Department of Abdominal Surgery and Transplantation

Study Record Dates

First Submitted

January 26, 2022

First Posted

March 9, 2022

Study Start

April 8, 2022

Primary Completion

September 1, 2025

Study Completion

March 1, 2026

Last Updated

September 11, 2023

Record last verified: 2023-09

Locations

BE(1)