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Clinical Trials in Italy / NCT06800469
Recruiting Not applicable

Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer

NCT06800469 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Not applicable
Started
2022-07-11
Last updated
2025-01-30

Condition(s) studied

Pancreatic Cancer, Adult

Investigational drug(s) / intervention(s)

Microbiota analysis

Microbiota analysis: Upon acquisition of informed consent, fecal, digiunal mucosa, biliary and pancreatic fluid samples will be collected for microbiota analysis

Study summary

Pancreatic head cancer represents one of the most frequent malignancies with an incidence of about 13500 new cases each year. The primary objective of the study is to test whether there are bacterial species associated with increased risk of complications in patients with peri-ampullary neoplasia undergoing DCP.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years * Diagnosis of resectable pancreatic adenocarcinoma with indication for "upfront" surgical treatment * ASA (American Society of Anesthesiology) score \< 4 * Obtaining informed consent Exclusion Criteria: \- Pregnant or lactating women

Primary outcome measure(s)

  • Structure of the gut microbiome — 7 days before surgery, 15 and 30 days after surgery thereafter
    The structure of the gut microbiome will be characterized on the samples by "next-generation sequencing" of the hypervariable region V3 to V4 of the 16S rRNA gene (bacterial component) and by "shotgun genomics"; ecosystem functionality will be assessed by measuring the fecal concentration of short-chain fatty acids (SCFA).

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna BO Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06800469 on ClinicalTrials.gov ↗ ← All trials in Italy