NCT02596646

Early Precut in Difficult Biliary Cannulation

Early Precut Sphincterotomy During ERCP With Difficult Biliary Access (Italian: Esecuzione Del Pre-cut Precoce in Corso di ERCP Con Difficoltosa Incannulazione Della Via Biliare)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: —
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques.

Detailed description

In this prospective multicenter randomized clinical trial the investigators assign patients referred for therapeutic biliary ERCP and difficult biliary cannulation (unsuccessful cannulation after 5 minutes) to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). Group A patients undergo precut immediately after randomization ("early precut"), while for group B cannulation attempts are continued for another 10 minutes, after which a precut is done if these fail or there are three unintended additional passages of the guide-wire into the MPD ("delayed precut").

Conditions

• Common Bile Duct Diseases

Interventions

Type	Name	Description
PROCEDURE	Early Precut	Early precut was performed during ERCP with difficult biliary cannulation
PROCEDURE	Prolonged cannulation attempts	Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2015-11-04
• Last updated: 2015-11-06

Locations

1 site across 1 country: Italy