Assessment of bile microbes in patients undergoing ERCP
Microbiological Assessment of Bile in Patients Undergone to Endoscopic Retrograde Cholangiography (ERCP): the "Microbile Registry"
This study is trying to see what kinds of bacteria are in the bile of patients getting a specific procedure for bile duct issues, including both non-cancerous and cancerous conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Unità Sanitaria Locale della Romagna Academic / other |
| Locations | 1 site (Forlì, Forlì-Cesena) |
| Trial ID | NCT06115564 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the microbial composition of bile in patients who are undergoing endoscopic retrograde cholangiography (ERCP) for various biliary conditions. It aims to include a diverse population with both benign and malignant indications for biliary drainage. The study will assess patients with naive papilla, meaning they have not previously undergone endoscopic sphincterotomy. The findings could provide insights into the role of bile microbiota in biliary diseases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who require ERCP for either benign or malignant biliary conditions.
Not a fit: Patients who have previously undergone endoscopic sphincterotomy or have anatomical alterations of the upper GI tract may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of bile microbiota's role in biliary diseases, potentially leading to improved treatment strategies.
How similar studies have performed: While the specific approach of assessing bile microbiota in this context may be novel, similar studies have shown promise in understanding the microbiome's role in various diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Main inclusion criteria for patient enrollment were: ability to provide an informed consent; age \>/=18 years; any benignant or malignant ERCP indication. All subjects were excluded from the study: * Patients who have already undergone endoscopic sphincterotomy * Patients unable to express informed consent * Pregnant or breastfeeding women * Patients with anatomical post-surgical alterations of the upper gastrointestinal (GI) tract
Where this trial is running
Forlì, Forlì-Cesena
- Ospedale Morgagni-Pierantoni — Forlì, Forlì-Cesena, Italy (Recruiting)
Study contacts
- Principal investigator: Carlo Fabbri, MD — AUSL Romagna
- Study coordinator: Carlo Fabbri, MD
- Email: carlo.fabbri@auslromagna.it
- Phone: +39 3389353104
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.