The Microbiome of Pancreatic Cancer: "PANDEMIC" Study

NCT04274972 | Unknown

• 1 other identifier: 2480CESC
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Microbial Colonization; Pancreas Cancer; Pancreas Infection; Pancreas; Fistula

Outcome Measures

Primary Outcomes (1)

• Microbiome evaluation

  Qualitative and quantitative analysis of the pancreatic microbiome in patients with PDAC submitted to pancreaticoduodenectomy, sampling intraoperatively the lesion

  30th day after surgery

Secondary Outcomes (3)

• Microbiome samples correlation

  30th day after surgery

• Microbiome correlation to surgical outcomes

  90th day after surgery

• Microbiome long-term evaluation

  90th day after surgery

Study Arms (1)

Pancreaticoduodenectomy patients

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.

Diagnostic Test: Microbiome evaluation

Interventions

Microbiome evaluation DIAGNOSTIC_TEST

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

Pancreaticoduodenectomy patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 patients will be submitted to the routinely diagnostic preoperative work-up.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

AOUI Verona

Verona, 37124, Italy

RECRUITING

MeSH Terms

Conditions

Communicable Diseases; Pancreatic Neoplasms; Pancreatic Fistula

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Digestive System Fistula; Fistula; Pathological Conditions, Anatomical

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 18, 2020
• Study Start: February 1, 2020
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

IT (1)