title: Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video).
abstract: OBJECTIVE
  Digital cholangioscopes provide higher-resolution imaging of the pancreatobiliary tract compared with fiberoptic instruments. The role of a new, digital, single-operator cholangiopancreatoscopy (SOC) system for diagnosis and treatment of pancreatobiliary disorders in clinical practice is not known.
  
  
  METHODS
  We performed a multicenter, observational study of 105 consecutive patients with suspected pancreatobiliary disorders. The main outcome measures were (1) sensitivity and specificity of SOC visual appearance and biopsies in the diagnosis of indeterminate biliary strictures and (2) achieving complete duct clearance in patients with biliary or pancreatic duct stones.
  
  
  RESULTS
  A total of 98 cholangioscopy and 7 pancreatoscopy procedures were performed in 105 patients. Superior views of the ductal lumen and mucosa were obtained in all 44 patients with indeterminate biliary strictures. Among the 44 patients who underwent SOC-guided biopsies, the specimen was adequate for histologic evaluation in 43 patients (97.7%). The sensitivity and specificity of SOC visual impression for diagnosis of malignancy was 90% (95% confidence interval [CI], 69.9%-97.2%) and 95.8% (95% CI, 79.8%-99.3%), respectively. The sensitivity and specificity of SOC-guided biopsies for diagnosis of malignancy was 85% (95% CI, 64.0%-94.8%) and 100% (95% CI, 86.2%-100%). In patients with biliary or pancreatic duct stones (N = 36), complete duct clearance with stone removal in 1 session was accomplished in 86.1% of patients (31/36). Three patients (2.9%) experienced SOC-related adverse events that included cholangitis in 2 patients and postprocedure pancreatitis in 1 patient.
  
  
  CONCLUSIONS
  SOC has become an integral part of the ERCP armamentarium and has high accuracy in the evaluation of indeterminate biliary strictures. Complete stone clearance was achieved in all but 1 patient with challenging biliary or pancreatic duct stones. (
  
  
  BACKGROUND
  NCT01815619.).
authors.affiliation: Center for Interventional Endoscopy, Orlando, Florida, USA.
authors.forename: Udayakumar
authors.initials: U
authors.lastname: Navaneethan
authors.affiliation: Center for Interventional Endoscopy, Orlando, Florida, USA.
authors.forename: Muhammad K
authors.initials: MK
authors.lastname: Hasan
authors.affiliation: Center for Interventional Endoscopy, Orlando, Florida, USA.
authors.forename: Kiran
authors.initials: K
authors.lastname: Kommaraju
authors.affiliation: Center for Interventional Endoscopy, Orlando, Florida, USA.
authors.forename: Xiang
authors.initials: X
authors.lastname: Zhu
authors.affiliation: Center for Interventional Endoscopy, Orlando, Florida, USA.
authors.forename: Shantel
authors.initials: S
authors.lastname: Hebert-Magee
authors.affiliation: Center for Interventional Endoscopy, Orlando, Florida, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Hawes
authors.affiliation: Center for Endoscopy and Pancreatobiliary Disorders, Cleveland Clinic, Cleveland, Ohio, USA.
authors.forename: John J
authors.initials: JJ
authors.lastname: Vargo
authors.affiliation: Center for Interventional Endoscopy, Orlando, Florida, USA.
authors.forename: Shyam
authors.initials: S
authors.lastname: Varadarajulu
authors.affiliation: Center for Endoscopy and Pancreatobiliary Disorders, Cleveland Clinic, Cleveland, Ohio, USA.
authors.forename: Mansour A
authors.initials: MA
authors.lastname: Parsi
mesh_terms: D000230:Adenocarcinoma / Q000150:complications / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D000368:Aged; D001649:Bile Duct Diseases / Q000175:diagnosis / Q000473:pathology / Q000601:surgery; D001650:Bile Duct Neoplasms / Q000150:complications / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D001662:Biliary Tract Surgical Procedures; D001706:Biopsy; D018281:Cholangiocarcinoma / Q000150:complications / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002761:Cholangitis / Q000453:epidemiology; D002769:Cholelithiasis / Q000150:complications / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D002779:Cholestasis / Q000175:diagnosis* / Q000209:etiology / Q000473:pathology / Q000601:surgery; D061765:Endoscopic Ultrasound-Guided Fine Needle Aspiration; D016145:Endoscopy, Digestive System; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010182:Pancreatic Diseases / Q000175:diagnosis / Q000473:pathology / Q000601:surgery; D010190:Pancreatic Neoplasms / Q000150:complications / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D010195:Pancreatitis / Q000453:epidemiology; D011183:Postoperative Complications / Q000453:epidemiology; D012189:Retrospective Studies; D012680:Sensitivity and Specificity