Clinical trial NCT06800469: Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer
Official title: Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer (MIcRobiome Analysis in Patients UnderGoing PancrEatico-duodenectomy for Pancreatic Cancer MIRAGE Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer, Adult
Keywords: pancreatic cancer
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Structure of the gut microbiome
timeFrame: 7 days before surgery, 15 and 30 days after surgery thereafter
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
state: BO
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Ricci Claudio, MD
role: PRINCIPAL_INVESTIGATOR
References: