Evaluating how the appearance of the major duodenal papilla affects post-ERCP pancreatitis risk
Prediction of Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis Based on the Appearance of the Major Duodenal Papilla: a Prospective, Observational, Cohort Study
This study is trying to see if the shape of a specific part of the intestine affects the risk of developing pancreatitis after a procedure called ERCP, which is used to treat bile duct problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1740 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 2 sites (Rome, Roma and 1 other locations) |
| Trial ID | NCT05800626 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the relationship between the morphological appearance of the major duodenal papilla and the occurrence of post-Endoscopic Retrograde CholangioPancreatography (ERCP) acute pancreatitis. By evaluating the difficulty of biliary cannulation based on papilla types, the study seeks to establish metrics for procedural quality and competence. The findings could help identify challenging cases that should be handled by experienced practitioners to reduce the risk of complications during ERCP procedures.
Who should consider this trial
Good fit: Ideal candidates include patients with a native duodenal papilla who require ERCP for biliary indications and can provide informed consent.
Not a fit: Patients undergoing ERCP for non-biliary disorders or those with previous gastrointestinal surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient safety and outcomes by minimizing the risk of post-ERCP acute pancreatitis.
How similar studies have performed: While this approach is observational and may build on existing knowledge, it is not widely tested in this specific context, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with native duodenal papilla; * Any indication to ERCP +/- biliary sphincterotomy of duodenal major papilla; * Patients able to provide a written informed consent Exclusion Criteria: * ERCP performed for disorders unrelated to biliary tract; * Previous upper gastrointestinal tract surgery; * Presence of a duodenal stricture (either malignant or benign); * Presence of a malignant infiltration of the papilla; * Concomitant anticoagulant and/or P2Y12 inhibitors therapy (clopidogrel, prasugrel, ticagrelor) that precludes the treatment; * INR \> 1.5; * Platelets count \< 80000/mm3; * Unwillingness to sign written informed consent.
Where this trial is running
Rome, Roma and 1 other locations
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Roma, Italy (Recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Ivo Boskoski
- Email: ivo.boskoski@policlinicogemelli.it
- Phone: +390630156580
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.