Abstract:Abstract: Objective To evaluate the effect of SpyGlass Direct Visualization System (SGDVS) in diagnosis of indeterminate biliary lesions and the treatment of complex bile duct stones. Methods The clinical data of 108 consecutive patients who underwent SGDVS for diagnosis or treatment between January 2015 and December 2017 was retrospectively reviewed. The measures of SGDVS diagnosis and treatment include: for detecting indeterminate biliary lesions, SpyGlass-guided biopsy and stones removal. The main outcomes were related to the procedure in terms of the following: visualization of the target lesions, SpyGlass-guided adequate tissue sampling and complete stone removal. Results 108 consecutive patients underwent SGDVS procedures. 76 patients (70.4%) were referred for indeterminate biliary strictures, 32 patients (29.6%) for stone removal. The total success rate of both diagnosis and treatment is 89.8% (97/108), 68 cases successfully completed diagnosis by SGDVS and the diagnostic success rate was 89.5% (68/76). Complete removal of stones were completed in 29 cases and the treatment success rate was 90.6% (29/32). The incidence of complications was 10.2% (11/108). Conclusion SGVDS can improve the accuracy of diagnosis of indeterminate biliary lesions through direct vision observation and adequate sampling. In addition, SGVDS combined with stone removal and lithotripsy equipment for complex bile duct stones, it can be safely performed with a high success rate.