NCT06800469

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

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

Study Start

First participant enrolled

July 11, 2022

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 30, 2025

Status Verified

December 1, 2024

Enrollment Period

3 years

First QC Date

January 9, 2025

Last Update Submit

January 28, 2025

Conditions

Pancreatic Cancer, Adult

Keywords

pancreatic cancer

Outcome Measures

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).

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

Study Arms (1)

Patients with adenocarcinoma of the pancreas

OTHER

Patients with adenocarcinoma of the pancreas needing surgical treatment by duodenocephalopancreasect

Diagnostic Test: Microbiota analysis

Interventions

Microbiota analysisDIAGNOSTIC_TEST

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

Patients with adenocarcinoma of the pancreas

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years
  • Diagnosis of resectable pancreatic adenocarcinoma with indication for "upfront" surgical treatment
  • ASA (American Society of Anesthesiology) score \< 4
  • Obtaining informed consent

You may not qualify if:

  • \- Pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Pancreatic cancer, adultPancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Ricci Claudio, MD

    IRCCS Azienda Ospedaliero-Universitaria di Bologna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudio Ricci, MD

CONTACT

+39 051 214 3928claudio.ricci@aosp.bo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2025

First Posted

January 30, 2025

Study Start

July 11, 2022

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

January 30, 2025

Record last verified: 2024-12

Locations

IT(1)