Clinical Trial: Early Precut in Difficult Biliary Cannulation

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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)

Brief 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 Summary: 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").
Sponsor: Università Vita-Salute San Raffaele

Current Primary Outcome: Incidence of PEP [ Time Frame: 24 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Incidence of overall complications [ Time Frame: 24 hours ]

The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.


Original Secondary Outcome: Incidence of overall complications [ Time Frame: 24 hours ]

We recorded the incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP, defined according to the protocol


Information By: Università Vita-Salute San Raffaele

Dates:
Date Received: September 7, 2015
Date Started: January 2012
Date Completion:
Last Updated: November 5, 2015
Last Verified: November 2015