Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04274972 |
| Other study ID # |
2480CESC |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2020 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
January 2023 |
| Source |
Azienda Ospedaliera Universitaria Integrata Verona |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Microbiome in patients affected by pancreatic ductal adenocarcinoma may present specific and
identifiable patterns. These variations could affect the surgical outcome and increase the
risk of life-threatening infections supported by multidrug-resistant bacteria. The
identification of microbial signatures with tumor specificity may have a potential role in
postoperative risk stratification. Variation of pancreatic, intestinal or bile microbiome and
their relationship can be investigated and measured as promising tools in order to predict
and overcome the clinical and infectious burden imposed by MDR infections. The prospect of a
potential role for probiotics to promote competition against the pathogens and to improve the
gastrointestinal barrier integrity has also been raised. Moreover, if the bacterial
composition in human PDAC was confirmed to be distinct from that of the normal pancreas,
microbiome variation could be used as a potential biomarker, to assess the potential for
malignancy in precursor neoplastic lesions. However, we believe that a preliminary and
explorative study is necessary. The study aims to outline the pancreatic microbiome of
patients who undergo upfront PD for resectable PDAC and to characterize the possible
association between bacterial composition and the occurrence of post-operative complications,
particularly POPF and IC.
Description:
Pancreatic cancer is predicted to become the second leading cause of cancer-related death in
the western world by 2030. Patients still have a poor prognosis, and a complete surgical
resection provides the only potential for long-term cure of pancreatic ductal adenocarcinoma
(PDAC) with a 5-year survival of only around 20%.
In addition, despite all the advances and technical modifications developed during this past
decade, pancreatic surgery is still hampered by considerable postoperative morbidity.
Postoperative pancreatic fistula (POPF), with a range of incidence between 3-45%, and the
infectious complications (IC) that occur in nearly one-third of the patients are still the
more frequent and dreadful complications after pancreatic resection. Moreover, in patients
submitted to pancreaticoduodenectomy (PD), the constantly growing presence of
multidrug-resistant (MDR) bacteria increases the morbidity and mortality rate. Those
complications may also limit access to adjuvant chemotherapy and result in higher costs and
longer hospitalization.
The high clinical burden of pancreatic surgery, associated with the overall poor outcome of
PDAC and worldwide diffusion of antibiotic resistance, suggest the urgent need to enhance our
knowledge on new and modifiable risk factors able to affect the surgical, the infectious and
the oncological outcomes.
The alteration of the microbiome recently emerged as a contributor to oncogenesis, as a risk
factor for postoperative morbidity in many intestinal tract malignancies and as one of the
leading causes of colonization by resistant pathogenic bacteria. Recent evidence suggests
that the pancreas also harbors its microbiome and in PDAC this is markedly more abundant and
with different patterns compared to a normal pancreas in both mice and humans. However, the
intestinal and PDAC microbiome have never been compared in humans. Alteration of the
microbiome induces an adaptive immune suppression and promotes an inflammatory status.
Growing literature evidence shows that the microbiome accounts for local and systemic
microenvironment changes. These alterations, characterized by immune suppression and
selection of potentially pathogenic bacteria, may lead both to adverse outcomes after
surgical treatment and to the overgrowth of multidrug-resistant flora.
Nevertheless, the etiologic relationship between intrapancreatic microbiota and postoperative
complications in PDAC patients subjected to surgery has not yet been described.
