NCT01954602

Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study

A Multicenter Randomized Trial Comparing the Use of Touch and no Touch Guide-wire Techniques for Deep Biliary Cannulation: the TNT Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Azienda Usl di Bologna · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Biliary Tract Diseases

Interventions

Type	Name	Description
PROCEDURE	Guide-wire cannulation	Direct guide-wire hovering a few millimeters through the catheter or sphincterotome
PROCEDURE	Sphincterotome assisted guide-wire cannulation	Sphincterotome is inserted initially a few millimeters through the papillary orifice

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2013-10-07
• Last updated: 2017-03-28

Locations

1 site across 1 country: Italy