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

Recruiting

• Conditions: Post-ERCP Acute Pancreatitis

• Registration Number: NCT05800626
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-03-24
• Study Start: 2023-04-01
• Study First Posted: 2023-04-05
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28
• Primary Completion: 2025-04-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1740

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of PEP occurrence	within 48 hours after the procedure	Rate of PEP occurrence distributed between the different native major duodenal papilla types

Secondary Outcome Measures

Name	Time	Method
occurrence of intra- and post-procedural complications	within 48 hours after the procedure	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
Rate of difficult biliary cannulation	during the procedure	Rate of difficult biliary cannulation distributed between the different types of the intramural papillary segments on fluoroscopic images
Difference in the rate of difficult biliary cannulation	during the procedure	Difference in the rate of difficult biliary cannulation between ERCP experts (\>300 performed procedures) and fellows (\<300 performed procedures)
Rate of intraoperative complications	during the procedure	Rate of intraoperative complications distributed between the different native major duodenal papilla types
Rate of postoperative complications except for PEP	within 48 hours after the procedure	Rate of postoperative complications except for PEP (up to 48 hours after ERCP) distributed between the different native major duodenal papilla types

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 Roma, Italy