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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1,740 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,740

Conditions

Post-ERCP Acute Pancreatitis

Interventions

Endoscopic Retrograde Cholangio-Pancreatography (ERCP)PROCEDURE

ERCP performed for clinical practice

Eligibility

Medical Language ↔ Plain English

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.

Locations (2)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Roma, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

RECRUITING

Outcomes

Primary Outcomes

Rate of PEP occurrence

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

Time frame: within 48 hours after the procedure

Secondary Outcomes

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

Time frame: 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

Time frame: during the procedure

Rate of intraoperative complications

Rate of intraoperative complications distributed between the different native major duodenal papilla types

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: within 48 hours after the procedure

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts