Clinical Trial: Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multicenter Randomized Trial Comparing the Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study
Brief Summary: The specific goal of this study is to compare the deep biliary cannulation rate and complication rates associated with use of touch and no touch guide-wire biliary cannulation techniques.
Detailed Summary:
The most common technique used to achieve primary deep biliary cannulation is the standard contrast-assisted method, in which a catheter or sphincterotome is introduced into the papilla in the direction of the bile duct and a contrast medium injected to confirm that the duct has been cannulated.
The biliary guidewire cannulation technique consists of the introduction of a guide-wire into the bile duct instead of contrast injection as the first maneuver.
The benefit of this technique, compared with classic contrast cannulation, has been demonstrated in several studies which show similar results and have been analyzed in a recent meta-analysis, including 5 studies and 1762 patients, and demonstrating that the use of the guide-wire technique significantly improved the primary cannulation rate from 74.9% to 85.3%. More importantly, significantly reduced the incidence of PEP from 8.6% to 1.6%.
There are several variations of this technique; the tip of the sphincterotome is inserted initially a few millimeters through the papillary orifice and then introduce the guide-wire to the target ("touch technique"). Another variation is direct cannulation with the guide-wire hovering a few millimeters through the catheter or sphincterotome ("no touch technique").
To date, there are no randomized controlled trials comparing the two above described way to access to biliary duct regarding efficacy and rate of complications.
Sponsor: Azienda Usl di Bologna
Current Primary Outcome: Cannulation success rate [ Time Frame: No more than 5 minutes of biliary cannulation or 5 unintended pancreatic duct cannulation with the guidewire, with both techniques ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Incidences of PEP [ Time Frame: from the intervention until two days ]
Original Secondary Outcome: Same as current
Information By: Azienda Usl di Bologna
Dates:
Date Received: August 5, 2013
Date Started: July 2013
Date Completion:
Last Updated: March 24, 2017
Last Verified: March 2017
