Diagnostic and therapeutic single-operator cholangiopancreatoscopy in biliopancreatic diseases：Prospective multicenter study in Japan

AIM To assess the utility and safety of single-operatorcholangiopancreatoscopy （SOCPS） using the SpyGlasssystem in widespread clinical application for biliary andpancreatic diseases.METHODS： This study was a prospective case seriesconducted in 20 referral centers in Japan. There were148 patients who underwent SOCPS; 124 for biliarydiseases and 24 for pancreatic diseases. The attemptedinterventions were SOCPS examination, SOCPS-directedtissue sampling, and therapy for stone removal,among others. The main outcomes were related to theprocedure success rate in terms of visualizing the targetlesions, SOCPS-directed adequate tissue sampling, andcomplete stone removal.RESULTS： A total of 148 patients were enrolled for thediagnosis of indeterminate biliary and pancreatic lesionsor treatment of biliary and pancreatic disease. Theoverall procedure success rate of visualizing the targetlesions was 91.2% （135/148）. The overall proceduralsuccess rates of visualizing the target lesions ofdiagnostic SOCPS in the bile duct and pancreatic ductwere 95.5% （84/89） and 88.2% （15/17）, respectively.Diagnosis： the overall adequate tissue for histologicexamination was secured in 81.4% of the 86 patientswho underwent biopsy under SOCPS （bile duct, 60/75,80.0%; pancreatic duct, 10/11, 90.9%）. The accuracyof histologic diagnosis using SOCPS-directed biopsiesin indeterminate bile duct lesions was 70.7% （53/75）.In the pancreatic duct, the accuracy of SOCPS visualimpression of intraductal papillary mucinous neoplasmwas 87.5% （14/16）. Stone therapy： complete biliaryand pancreatic stone clearance combined withSOCPS-directed stone therapy using electrohydrauliclithotripsy or laser lithotripsy was achieved in 74.2%（23/31） and 42.9% （3/7） of the patients, respectively.Others： SOCPS using the SpyGlass system was used incannulation of the cystic duct in two patients and forpassing across the obstructed self-expandable metallicstent for a malignant biliary stricture in two patients.All procedures were successful in both SOCPS-guidedtherapies. The incidence of procedure-related adverseevents was 5.4% （8/148）.CONCLUSION： SOCPS with direct visualization andbiopsy for diagnosis and SOCPS-directed therapy forbiliary and pancreatic diseases can be safely performedwith a high success rate.