Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Pancreatic Cancer, Adult

Treatments: Diagnostic Test: Microbiota analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT06800469

MIRAGE study

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Patients with adenocarcinoma of the pancreas

Other group

Description:

Patients with adenocarcinoma of the pancreas needing surgical treatment by duodenocephalopancreasect

Treatment:

Diagnostic Test: Microbiota analysis