Background. The SpyGlass Direct Visualization System (Boston Scientific, Natick, MA) is routinely used during single operator choledochoscopy (SOC) to identify biliary lesions or strictures with a diagnostic accuracy up to 88%. The objective of this study was to determine the interobserver agreement (IOA) of modified scoring criteria for diagnosing biliary lesions/strictures. Methods. 27 SPY SOC video clips were reviewed and scored by 9 interventional endoscopists based on published criteria that included the presence and severity of surface structure, vasculature visualization, lesions, and findings. Results. Overall IOA was “slight” for all variables. The K statistics are as follows: surface (, SE？=？0.02); vessels (, SE？=？0.02); lesions (, SE？=？0.02); findings (, SE？=？0.03); and final diagnosis (, SE？=？0.02). The IOA for “findings” and “final diagnosis” was also only “slight.” The final diagnosis was malignant (11), benign (11), and indeterminate (5). Conclusion. IOA using the modified criteria of SOC images was slight to almost poor. The average accuracy was less than 50%. These findings reaffirm that imaging criteria for benign and malignant biliary pathology need to be formally established and validated. 1. Introduction The role of cholangioscopy in the diagnosis of biliary strictures is being more widely advocated with increased availability of cholangioscopy systems. The earlier “mother-daughter” systems introduced in the 1970s are being replaced in many practices by the single operator cholangioscopy system (SOCS), which overcomes many of the limitations of these older instruments. The SpyGlass Direct Visualization System (Boston Scientific, Natick, MA) is currently the only SOCS commercially available in the United States. Advantages that this device offers over the older systems include four-way steerability, dedicated irrigation channels, and a 1.2？mm working channel through which diagnostic and therapeutic devices can be used [1, 2]. Peroral video cholangioscopy systems (PVCS) are also available in select Asian countries and on trial basis in the United States and provide superior imaging quality. Common indications for cholangioscopy are stone therapy and evaluation of indeterminate biliary strictures [1–6]. Studies using the SOCS report diagnostic sensitivities for malignancy of 66–78% and specificities of 82–98% [7, 8]. Reports using the PVCS report sensitivity of 100% and specificity of >90% [9]. While the largest multicenter study using SOCS demonstrated high diagnostic accuracy with visualization alone, there was no indication of
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