Prediction of PEP Based on the Appearance of the Major Duodenal Papilla (PredERCP)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Post-ERCP Acute Pancreatitis

Treatments: Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

Study type: Observational

Funder types: Other

Identifiers

NCT05800626

5534

Details and patient eligibility

About

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.

Enrollment: 1,740 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.