Analyzing gut bacteria in pancreatic cancer surgery patients
Gut Microbiota Analysis in Patients Undergoing Duodencephalopancreasectomy for Pancreatic Cancer (MIcRobiome Analysis in Patients UnderGoing PancrEatico-duodenectomy for Pancreatic Cancer MIRAGE Study)
This study is trying to see if certain gut bacteria in patients having surgery for pancreatic cancer can help predict complications after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT06800469 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between gut microbiota and postoperative complications in patients undergoing duodenocephalopancreasectomy for pancreatic cancer. It aims to identify specific bacterial species that may be associated with increased risks of complications such as pancreatic and biliary fistulas. By analyzing the gut microbiota, the study seeks to provide insights that could improve surgical outcomes and reduce morbidity. The research is based on preliminary findings from other surgical fields suggesting that gut bacteria may influence recovery and complication rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with resectable pancreatic adenocarcinoma who are eligible for upfront surgical treatment.
Not a fit: Patients who are pregnant or lactating will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing surgery for pancreatic cancer.
How similar studies have performed: Preliminary studies in colorectal surgery have shown success in linking gut microbiota to surgical outcomes, suggesting potential for this approach in pancreatic cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna, BO
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bo, Italy (Recruiting)
Study contacts
- Principal investigator: Ricci Claudio, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Claudio Ricci, MD
- Email: claudio.ricci@aosp.bo.it
- Phone: +39 051 214 3928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.