Early Precut in Difficult Biliary Cannulation

Common Bile Duct Diseases Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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"). ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Diseases
• Common Bile Duct Diseases

• NCT number: NCT02596646
• Study type: Interventional
• Source: Università Vita-Salute San Raffaele
• Status: Terminated
• Phase: N/A
• Start date: January 2012
• Completion date: December 2013