ORIGINAL ARTICLE: Clinical Endoscopy SpyGlass single-operator peroral cholangiopancreatoscopy system for the diagnosis and therapy of bile-duct disorders: a clinical feasibility study (with video) Yang K. Chen, MD, Douglas K. Pleskow, MD Denver, Colorado, Boston, Massachusetts, USA Background: Clinical implementation of cholangioscopy for direct visual examination of bile ducts, tissue sam- pling, and therapeutic maneuvers has been slowed by limitations in available technology. With 4-way deflected steering and dedicated irrigation channels, the single-operator SpyGlass peroral cholangiopancreatoscopy system is designed to overcome some of these limitations. Objective: To evaluate the clinical utility and safety of the SpyGlass system for diagnostic and therapeutic endoscopic procedures in bile ducts. Design: Prospective observational clinical feasibility study. Setting: Two tertiary referral centers. Main Outcome Measurements: Procedural success rate defined as the proportion of SpyGlass procedures in which the diagnostic or therapeutic objectives of the procedure were achieved. Results: SpyGlass procedures were performed in 35 patients: 22 with indeterminate strictures (63%), 5 with indeterminate filling defects (14%), 5 with stones (14%), 2 with cystic lesions (6%), and 1 patient with an indi- cation for gallbladder stent placement (3%). The rate of procedural success was 91% (95% confidence interval 77%-98%). Twenty patients underwent SpyGlass-directed biopsy, and the specimens procured from 19 patients (95%) were found adequate for histologic evaluation. The preliminary sensitivity and specificity of SpyGlass- directed biopsy to diagnose malignancy were 71% and 100%, respectively. SpyGlass-directed electrohydraulic lithotripsy succeeded in 5 of 5 patients (100%). Procedure-related complications occurred in 2 patients (6%) and resolved uneventfully. Limitations: No control group was included. Follow-up for determining preliminary sensitivity and specificity was limited. Conclusions: SpyGlass procedures proved to be clinically feasible, provided adequate samples for histologic diagnosis, and successfully guided stone therapy. The procedures were safe and well tolerated. Prospective mul- ticenter clinical trials of the system are underway. (Gastrointest Endosc 2007;65:832-41.) ERCP is a standard method for the evaluation of bile- duct disorders. In the diagnosis of malignant biliary stric- tures, the reported sensitivity of ERCP-directed forceps biopsy ranges widely, from 43% to 81%. 1 Cholangiopan- creatoscopy (CP), which facilitates direct visual assess- ment, visually guided tissue sampling, and therapeutic intervention, holds promise as an advanced technique in cases that elude successful diagnosis or treatment by conventional ERCP or other imaging modalities. Although the percutaneous route can be used, the peroral approach is preferred for accessing the biliary tree, because percuta- neous CP is more invasive, requiring either a hepatic punc- ture, with formation of a biliocutaneous fistula, or entry via a surgical T-tube tract. The utility of peroral CP in dif- ferentiating between biliary malignant and benign stric- tures and filling defects has been described in a number of reports. 2-6 CP-directed forceps biopsy can be of value in diagnosing bile-duct lesions with relatively high sensitiv- ity and specificity. 7,8 Under direct visualization, subtle Copyright ª 2007 by the American Society for Gastrointestinal Endoscopy 0016-5107/$32.00 doi:10.1016/j.gie.2007.01.025 832 GASTROINTESTINAL ENDOSCOPY Volume 65, No. 6 : 2007 www.giejournal.org