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

Study Overview
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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.

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

Conditions
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Post-ERCP Acute Pancreatitis

Intervention / Treatment
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* Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic Retrograde Cholangio-Pancreatography (ERCP)|ERCP performed for clinical practice|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (> 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 distributed between the different types of the intramural papillary segments on fluoroscopic images |  | during the procedure | 
| Rate of intraoperative complications distributed between the different native major duodenal papilla types |  | during the procedure | 
| 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 between ERCP experts (>300 performed procedures) and fellows (<300 performed procedures) |  | during 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 |  | within 48 hours after the procedure |