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

Post-ERCP Acute Pancreatitis Clinical Trial

— PredERCP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05800626
• Other study ID #: 5534
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Ivo Boskoski
• Phone: +390630156580
• Email: ivo.boskoski[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1740
• Est. completion date: December 31, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Procedure:
• Endoscopic Retrograde Cholangio-Pancreatography (ERCP)
ERCP performed for clinical practice

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of PEP occurrence	Rate of PEP occurrence distributed between the different native major duodenal papilla types	within 48 hours after the procedure
Secondary	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
Secondary	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
Secondary	Rate of intraoperative complications	Rate of intraoperative complications distributed between the different native major duodenal papilla types	during the procedure
Secondary	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
Secondary	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
Secondary	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