Pancreatic Cancer, Adult
Conditions
Keywords
pancreatic cancer
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.
Interventions
DIAGNOSTIC_TESTMicrobiota analysis
Upon acquisition of informed consent, fecal, digiunal mucosa, biliary and pancreatic fluid samples will be collected for microbiota analysis
Sponsors
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Italy
Contacts
Primary ContactClaudio Ricci, MD
Outcome results
None listed