Prospective randomized trial of a new multibending versus conventional ultra-slim endoscope for peroral cholangioscopy without device or endoscope assistance (with video)

Abstract

BACKGROUND AND AIMS: Currently available peroral cholangioscopy (POC) is a duodenoscopy-assisted procedure that does not involve directly inserting an endoscope into the biliary tree. A prototype multibending (MB) ultra-slim endoscope has been developed as a dedicated cholangioscope to overcome the technical difficulties of direct POC. Inthis study, we evaluated the efficacy of the new MB ultra-slim endoscope compared with a conventional ultra-slim endoscope for free-hand insertion of an endoscope into the bile duct for direct POC without the assistance of accessories. METHODS: Ninety-two patients with biliary disease requiring diagnostic and/or therapeutic direct POC were assigned randomly to groups examined using an MB ultra-slim endoscope (MB group, n=46) versus a conventional ultra-slim endoscope (conventional group, n=46). The primary outcome was the technical success of free-hand insertion of the endoscope during direct POC, defined as successful insertion of the endoscope through the ampulla of Vater and advancement of the endoscope up to the bifurcation or to the obstructed segment of the biliary tree without any accessories within 15 minutes. RESULTS: Free-hand biliary insertion of the endoscope for direct POC was technically successful in 41 patients (89.1%)in the MB group, which was significantly higher than the rate (14 patients, 30.4%) in the conventional group (P< .001). The procedure time (mean ± standard deviation) of direct POC using free-hand biliary insertion of the endoscope was significantly shorter in the MB group than in the conventional group (3.2 ± 1.8 vs 6.0 ± 3.0 minutes, P= .004). Adverse events were observed in 3 patients (6.5%) in the MB group and 2 patients (4.3%) in the conventional group (P= .500), all of whom were treated conservatively. The technical success rates of the diagnostic or therapeutic intervention were not significantly different between the 2 groups in patients undergoing successful direct POC. CONCLUSIONS: Free-hand biliary insertion of the MB ultra-slim endoscope showed a high technical success rate without severe adverse events and effectively decreased procedure time compared with a conventional ultra-slim endoscope. Direct POC using the MB ultra-slim endoscope can be used for novel diagnostic and therapeutic procedures of the biliary tree without the assistance of another endoscope or accessory. (Clinical trial registration number: NCT02189421.).