UnknownNot Applicable

Prediction of PEP Based on the Appearance of the Major Duodenal Papilla

Italy1,740 participantsStarted 2023-04-01

Plain-language summary

This observational, prospective study aims at evaluating how the occurrence of post-Endoscopic Retrograde CholangioPancreatography (ERCP) acute pancreatitis (PEP) could be influenced by difficult biliary cannulation that might be previously assessed by the morphological appearance of native major papilla in all the patients undergoing ERCP. The rate of successful biliary cannulation across papilla types could be used as intraprocedural quality and competence metrics during training. Moreover, recognizing difficult papillae could allow reserving those to experts to decrease the odds of failed cannulation.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of PEP occurrence

Timeframe: within 48 hours after the procedure

Trial details

NCT IDNCT05800626

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-04-01

Contact for this trial

Ivo Boskoski

+390630156580 ivo.boskoski@policlinicogemelli.it

View on ClinicalTrials.gov More Post-ERCP Acute Pancreatitis trials