Abstract

A new type of sphincterotome released to the market recently has high rotation performance and a freely bendable blade. It is devised to be singly capable of accommodating not only normal anatomy but also cases with surgically altered anatomy. This study was undertaken for clinical evaluation of the usefulness of this new sphincterotome. Eight cases in a reconstructed intestine for which cannulation or endoscopic sphincterotomy (EST) had been performed were extracted from 32 cases for which endoscopic retrograde cholangiopancreatography-related procedures were performed using the sphincterotome developed during November 2023 through February 2024. The cases were investigated retrospectively. Among these, EST was applied to six cases. Cannulation was performed using the developed sphincterotome in the native papilla in four cases. The primary endpoints were the success rate of cannulation in surgically altered anatomy and the success rate of EST. Secondary endpoints were complications and usability for operators. Usability for operators was evaluated by questionnaire for several items on a 5-point scale. EST was conducted successfully in all six cases subjected to EST. Mild hemorrhage was observed in one case (17%) as an adverse event after EST. Deep cannulation to the native papilla with the developed sphincterotome was conducted successfully in three cases (75.0%). Evaluation results by operators were 4.4 ± 0.55 for rotation performance, 4.00 ± 0.63 for incision performance, 4.29 ± 0.49 for deep cannulation performance, and 4.07 ± 0.19 for overall evaluation. In conclusion, this developed sphincterotome might be very useful for EST and cannulation in cases with surgically altered anatomy.

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