A prospective randomized controlled multicenter trial of duodenoscopes with 5° and 15° backward-oblique angle using wire-guided cannulation : effects on selective cannulation of the common bile duct in endoscopic retrograde cholangiopancreatography

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Background. In duodenoscopy, during endoscopic retrograde cholangiopancreatography (ERCP), a backward-oblique angle duodenoscope (BOAD) is generally used. In Japan, 15° BOAD are mainly used, but in Western countries, 5° BOAD are mostly used. In bile duct cannulation associated with ERCP, a catheter for contrast imaging is used in Japan, but wire-guided cannulation (WGC) using a papillotome is standard in Western countries. We conducted a randomized controlled multicenter trial to evaluate the contributions of different duodenoscopes using WGC to selective common bile duct cannulation. Methods. Subjects comprised 179 consecutive patients who underwent ERCP. Patients were randomized into the 15° BOAD group (15° group, n = 90) or the 5° BOAD group (5° group, n = 89). Results. The duodenal papilla could not be accessed endoscopically in two cases from each group. Success rates for bile duct cannulation by WGC without bow-up for the 15° and 5° groups were 85.6% and 56.2%, respectively (P < 0.01). Success rates for bile duct cannulation by WGC with bow-up for the 15° and 5° groups were 88.9% and 78.7%, respectively. Total rates of bile duct cannulation for the 15° and 5° groups were 94.4% and 92.1%, respectively. As for accidents, incidences of acute pancreatitis for the 15° and 5° groups were 5.6% and 9.0%, respectively, with no significant difference seen. Conclusions. With 15° BOAD, bile duct cannulation was favorable without papillotome bow-up. With 5° BOAD, the success rate of WGC may be improved by adjusting the angle based on papillotome bow-up.

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