Developing a predictive score for complications after ERCP procedures
Studio Osservazionale Per lo Sviluppo di Uno Score Predittivo Degli Eventi Avversi Post-colangiopancreatografia Retrograda Endoscopica (ERCP)
This study is trying to find out what factors can lead to complications after ERCP procedures to help predict risks for patients undergoing this treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 981 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06776874 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify independent factors that increase the risk of complications following endoscopic retrograde cholangiopancreatography (ERCP). It will develop and validate a predictive model for adverse events based on data collected from patients undergoing ERCP. The study also seeks to evaluate the rate of post-ERCP complications across participating centers, addressing limitations in previous research regarding risk factor identification and complication rates.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with hepato-biliary-pancreatic diseases requiring ERCP treatment.
Not a fit: Patients who do not require ERCP or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and prevention strategies for patients undergoing ERCP, potentially reducing the incidence of adverse events.
How similar studies have performed: Previous studies have attempted to identify risk factors for ERCP complications, but this study aims to provide a more precise and validated predictive model, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Patients admitted with hepato-biliary-pancreatic disease or other pathological conditions that require treatment by ERCP * Obtaining informed consent Exclusion Criteria: * None
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Lorenzo Lorenzo, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Lorenzo Fuccio, MD
- Email: lorenzo.fuccio@aosp.bo.it
- Phone: 0512143338
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.