Clinical trial · Observational
The Microbiome of Pancreatic Cancer: "PANDEMIC" Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Microbial Colonization | — | UNRESOLVED | — |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Pancreas; Fistula | — | UNRESOLVED | — |
| Pancreas Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microbiome evaluation | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Pancreaticoduodenectomy patients
- description
- All patients, affected by a resectable PDAC of the head of the pancreas, visited at the Department of Pancreatic Surgery of Verona, will be enrolled. All the patients must be scheduled for an elective PD. The oral and rectal microbiome samples will be collected preoperatively. The PDAC tissue from the surgical specimen, the intestinal mucosal tissue from the enteric side of the pancreatic anastomosis, and the bile sample will be collected intraoperatively. On the 30th postoperative day, the oral and rectal samples will be repeated.
- interventionNames
- Diagnostic Test: Microbiome evaluation
Primary outcomes (1)
- measure
- Microbiome evaluation
- timeFrame
- 30th day after surgery
- description
- Qualitative and quantitative analysis of the pancreatic microbiome in patients with PDAC submitted to pancreaticoduodenectomy, sampling intraoperatively the lesion
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * age between 18 and 65 years; * PDAC lesion of the pancreatic head confirmed by preoperative histology or cytology; * Scheduled for elective PD; * ASA score \< 4 * The ability of the subject to understand the character and individual consequences of the clinical trial * Written informed consent Exclusion Criteria: * Patients with a degenerated pancreatic cyst lesion * Neoadjuvant treatment (both radio and chemotherapy) * Other current malignancies * Antibiotic therapy during 4 weeks before surgery * History of gastrointestinal tract resections or chronic gastrointestinal diseases * Pregnant or breastfeeding patients * Patients undergoing emergency surgery * ASA score \> 4 * Impaired mental state or language problems
References
Publications (0)
Data not yet available