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Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer


2022-07-11


2025-07-01


2025-07-01


30

Study Overview

Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer

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.

Pancreatic head cancer represents one of the most frequent malignancies with an incidence of about 13500 new cases each year. The only curative strategy for such neoplasm is still surgical resection by duodenocephalopancreasectomy (DCP) surgery. However, this procedure has a postoperative morbidity of about 70% with a severe complication rate of 20%. The most frequent complications are pancreatic fistula, biliary fistula, and infectious complications in general. These complications often account for a high postoperative mortality rate that even in high-volume centers reaches 5%. Although some predictive risk factors are known (comorbidities and the patient's age, the consistency of the pancreatic stump to be anastomized and/or type of pathology treated), there is still no study that has evaluated the influence of the gut microbiota in the determinism of complications. This hypothesis appears suggestive and supported by indirect evidence from the literature. Some preliminary studies performed in the field of colo-rectal surgery have shown that the presence of certain bacterial families such as Lachnospiraceae or Bacteroidaceae are correlated with a significant increase in anastomotic dehiscence. Low microbial diversity also appears to be correlated with increased risk of anastomotic dehiscence. In contrast, the presence of other species such as Prevotella copri or Streptococcus genus seem to correlate with a reduced risk of dehiscence. 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. Other objectives to be verified are: 1. the association between bacterial species and the occurrence of pancreatic fistula in terms of frequency and severity 2. the association between bacterial species and the occurrence of biliary fistula in terms of frequency and severity 3. the association between bacterial species and the occurrence of infectious complications of any kind.

  • Pancreatic Cancer, Adult
  • DIAGNOSTIC_TEST: Microbiota analysis
  • MIRAGE study

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2025-01-09  

N/A  

2025-01-28  

2025-01-28  

N/A  

2025-01-30  

2025-01-30  

N/A  

2024-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
OTHER: Patients with adenocarcinoma of the pancreas

Patients with adenocarcinoma of the pancreas needing surgical treatment by duodenocephalopancreasect

DIAGNOSTIC_TEST: Microbiota analysis

  • Upon acquisition of informed consent, fecal, digiunal mucosa, biliary and pancreatic fluid samples will be collected for microbiota analysis
Primary Outcome MeasuresMeasure DescriptionTime Frame
Structure of the gut microbiomeThe 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
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Claudio Ricci, MD

Phone Number: +39 051 214 3928

Email: claudio.ricci@aosp.bo.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Ricci Claudio, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available