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

摘要

BACKGROUND: In duodenoscopy, during endoscopic retrograde cholangiopancreatography (ERCP), a backward-oblique angle duodenoscope (BOAD) is generally used. In Japan, 15 degrees BOAD are mainly used, but in Western countries, 5 degrees 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 degrees BOAD group (15 degrees group, n = 90) or the 5 degrees BOAD group (5 degrees 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 degrees and 5 degrees 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 degrees and 5 degrees groups were 88.9 and 78.7%, respectively. Total rates of bile duct cannulation for the 15 degrees and 5 degrees groups were 94.4 and 92.1%, respectively. As for accidents, incidences of acute pancreatitis for the 15 degrees and 5 degrees groups were 5.6 and 9.0%, respectively, with no significant difference seen. CONCLUSIONS: With 15 degrees BOAD, bile duct cannulation was favorable without papillotome bow-up. With 5 degrees BOAD, the success rate of WGC may be improved by adjusting the angle based on papillotome bow-up.