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NCT Number: NCT06800469

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, BO, 40138, Italy

Location status: Recruiting

Location contact

Claudio Ricci, MD

CONTACT

[email protected]

+39 051 214 3928

About this study

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:

  • the association between bacterial species and the occurrence of pancreatic fistula in terms of frequency and severity
  • the association between bacterial species and the occurrence of biliary fistula in terms of frequency and severity
  • the association between bacterial species and the occurrence of infectious complications of any kind.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbiota analysis

Diagnostic Test

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

Primary outcomes

  1. Structure of the gut microbiome

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Claudio Ricci, MD

CONTACT

[email protected]

+39 051 214 3928

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer (MIcRobiome Analysis in Patients UnderGoing PancrEatico-duodenectomy for Pancreatic Cancer MIRAGE Study)

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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