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

NCT05800626 | Unknown

• 1 other identifier: 5534
• Study Type: observational
• Target: 1,740
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Rate of PEP occurrence

  Rate of PEP occurrence distributed between the different native major duodenal papilla types

  within 48 hours after the procedure

Secondary Outcomes (6)

• Rate of difficult biliary cannulation

  during the procedure

• Rate of difficult biliary cannulation

  during the procedure

• Rate of intraoperative complications

  during the procedure

• Rate of postoperative complications except for PEP

  within 48 hours after the procedure

• Difference in the rate of difficult biliary cannulation

  during the procedure

Interventions

Endoscopic Retrograde Cholangio-Pancreatography (ERCP) PROCEDURE

ERCP performed for clinical practice

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will include all consecutive patients with a native major duodenal papilla undergoing ERCP. Patients that previously underwent ERCP with sphincterotomy will not be included. Patients will be considered enrolled after signing the informed consent form. All patients will be hospitalized for at least 24 hours after ERCP for clinical observation.

You may qualify if:

• Patients with native duodenal papilla;
• Any indication to ERCP +/- biliary sphincterotomy of duodenal major papilla;
• Patients able to provide a written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Roma, 00168, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Central Study Contacts

Ivo Boskoski

CONTACT

+390630156580; ivo.boskoski@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 5, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: December 31, 2025
• Last Updated: February 28, 2024

Record last verified: 2023-03

Locations

IT (2)