ERCP procedures
Participating endoscopists agreed to use the single-use duodenoscope in place of other brands of duodenoscope(s) used in the endoscopy unit for ERCP. Endoscopists’ level of experience was categorized as “expert” (> 2000 lifetime ERCPs) and “less expert” (≤ 2000 lifetime ERCPs). Start and stop times of the procedure, post-procedure subjective feedback on performance-related attributes, American Society for Gastrointestinal Endoscopy (ASGE) grade for complexity of the ERCP procedure, and all attempted or completed maneuvers during the ERCP were documented. Device deficiencies were recorded and reported, regardless of whether they led to an AE or inability to complete the ERCP. If the necessary maneuvers could not be completed with the single-use device and the endoscopist crossed over to use a reusable duodenoscope, the reason for noncompletion with the single-use device was recorded, and the ability to complete the ERCP maneuvers with a reusable duodenoscope was documented.
Difficult common bile duct (CBD) cannulation was defined by a modification of the European Society of Gastrointestinal Endoscopy (ESGE) definition
