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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1740 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Post-ERCP Acute Pancreatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endoscopic Retrograde Cholangio-Pancreatography (ERCP)

ERCP performed for clinical practice

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No