Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer, Adult

• Registration Number: NCT06800469
• Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Timeline

• Study Start: 2022-07-11
• Status Verified: 2024-12
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-28
• Last Update Submitted: 2025-01-28
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Structure of the gut microbiome	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).

Trial Locations

Locations (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna; 🇮🇹 Bologna, BO, Italy