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 range18 Years – 100 Years

SexALL

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.

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