A multicenter randomized trial comparing the use of touch versus no-touch guidewire technique for deep biliary cannulation: the TNT study.

ABSTRACT

BACKGROUND AND AIMS: There are 2 techniques described for selective bile duct guidewire cannulation, the touch (T) technique (engaging the papilla with a sphincterotome and then advancing the guidewire) and the no-touch (NT) technique (engaging the papilla only with the guidewire). The aim of this prospective, multicenter randomized study was to compare the outcomes of the 2 guidewire cannulation techniques. METHODS: Three hundred consecutive patients with naïve papillae were enrolled in 2 groups (150 to T group and 150 to NT group). A maximum of 15 biliary cannulation attempts, for no longer than 5 minutes, or a maximum of 5 unintentional cannulations of the pancreatic duct for each group were performed. If biliary cannulation failed, the patient was crossed over to the other technique with the same parameters. The primary outcome was the guidewire cannulation success rate using either the T or NT technique. Secondary outcomes were the number of attempts and cannulation duration, number of pancreatic duct cannulations, and adverse events. RESULTS: The primary cannulation rate was significantly higher in the T group compared with the NT group (88% vs 54%, P < .001), and the cannulation rate was significantly higher using the T technique compared with the NT technique also after crossover (77% vs 17%, P < .001). The mean number of cannulation attempts was 4.6 in the T group versus 5.5 in the NT group (P = .006), and the duration of cannulation before crossover (P < .001) and overall cannulation duration after crossover (P < .001) were significantly lower in the T group. The number of unintended pancreatic duct cannulations was statistically higher using the T technique compared with the NT technique (P = .037). The rates of adverse events did not significantly differ between the 2 groups. CONCLUSIONS: Our results clearly indicated that the T technique is superior to the NT technique for biliary cannulation. (Clinical trial registration number NCT01954602.).