Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Diagnosis of resectable pancreatic adenocarcinoma with indication for "upfront" surgical treatment

ASA (American Society of Anesthesiology) score < 4

Obtaining informed consent

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Microbiota analysis

    Diagnostic test

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients with adenocarcinoma of the pancreasOther 1 intervention

Trial outcomes

Primary outcomes

1

Structure of the gut microbiome

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).

Time frame
7 days before surgery, 15 and 30 days after surgery thereafter

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.