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

Prediction of Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis Based on the Appearance of the Major Duodenal Papilla: a Prospective, Observational, Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Post-ERCP Acute Pancreatitis
• Intervention / Treatment: Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

• Study Type: Observational
• Enrollment (Estimated): 1740

Contacts and Locations

• Study Contact: Name: Ivo Boskoski; Phone Number: +390630156580; Email: ivo.boskoski@policlinicogemelli.it

Study Locations

• Italy
  • Roma, Italy, 00168
    • Recruiting
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Contact: IVO BOSKOSKI; Phone Number: +390630155701; Email: ivo.boskoski@policlinicogemelli.it
    • Principal Investigator: IVO BOSKOSKI
  • Roma
    • Rome, Roma, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
      • Contact: Ivo Boskoski, MD, PhD; Phone Number: 00390630156580; Email: ivo.boskoski@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of PEP occurrence	Rate of PEP occurrence distributed between the different native major duodenal papilla types	within 48 hours after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of difficult biliary cannulation	Rate of difficult biliary cannulation (> 5 cannulation attempts and/or > 5 minutes attempting to cannulate biliary duct and/or at least one passage in the pancreatic duct) distributed between the different native major duodenal papilla types	during the procedure
Rate of difficult biliary cannulation	Rate of difficult biliary cannulation distributed between the different types of the intramural papillary segments on fluoroscopic images	during the procedure
Rate of intraoperative complications	Rate of intraoperative complications distributed between the different native major duodenal papilla types	during the procedure
Rate of postoperative complications except for PEP	Rate of postoperative complications except for PEP (up to 48 hours after ERCP) distributed between the different native major duodenal papilla types	within 48 hours after the procedure
Difference in the rate of difficult biliary cannulation	Difference in the rate of difficult biliary cannulation between ERCP experts (>300 performed procedures) and fellows (<300 performed procedures)	during the procedure
occurrence of intra- and post-procedural complications	To evaluate the occurrence of intra- and post-procedural complications but PEP, fluoroscopic morphology of the papillary segment of distal bile duct, perioperative and intraoperative risk factors	within 48 hours after the procedure

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 24, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: 5534

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No