title: Prospective evaluation of digital single-operator cholangioscope for diagnostic and therapeutic procedures (with videos).
abstract: OBJECTIVE
  Recently, the digital single-operator cholangioscope (SPY-DS) has become available. This system may allow diagnosis by direct visualization and allow performance of various therapeutic procedures. The aim of the present study was to prospectively evaluate the clinical utility of DSOCS for diagnostic and therapeutic procedures for biliary disease.
  
  
  METHODS
  Technical success was defined as successful visualization of target lesions in the biliary tract and carrying out forceps biopsy as a diagnostic procedure, and successfully carrying out treatment such as guidewire insertion for the area of interest, electrohydraulic lithotripsy (EHL), or migrated stent removal. Also, the present study aimed at investigating diagnostic yield of the cholangioscopic findings and biopsy specimens.
  
  
  RESULTS
  A total of 55 consecutive patients were prospectively enrolled in this study; a diagnostic procedure was done in 33 patients, and a therapeutic procedure was done in 22 patients. Overall accuracy of visual findings was 93%, with a sensitivity of 83%, a specificity of 89%, positive predictive value (PPV) of 83%, and negative predictive value (NPV) of 100%. However, the overall accuracy of forceps biopsy was 89%, with a sensitivity, specificity, and PPV of 100%, and NPV of 90%. Overall technical success rate of therapeutic procedures such as selective guidewire insertion, EHL or migrated stent removal was 91% (20/22). Finally, adverse events were seen in two cases in the diagnostic group, but were not seen in the therapeutic group.
  
  
  CONCLUSIONS
  Although additional cases and a randomized, controlled study with another cholangioscope are needed, diagnostic and therapeutic procedures using SPY-DS appear to be feasible and safe.
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Takeshi
authors.identifier: http://orcid.org/0000-0003-2916-6568
authors.initials: T
authors.lastname: Ogura
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Miyuki
authors.initials: M
authors.lastname: Imanishi
authors.affiliation: Department of Pathology, Osaka Medical College, Osaka, Japan.
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Kurisu
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Saori
authors.initials: S
authors.lastname: Onda
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Tastsushi
authors.initials: T
authors.lastname: Sano
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Wataru
authors.initials: W
authors.lastname: Takagi
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Okuda
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Miyano
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Mio
authors.initials: M
authors.lastname: Amano
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Nobu
authors.initials: N
authors.lastname: Nishioka
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Tadahiro
authors.initials: T
authors.lastname: Yamada
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Masuda
authors.affiliation: Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
authors.forename: Mamoru
authors.identifier: http://orcid.org/0000-0001-7308-4311
authors.initials: M
authors.lastname: Takenaka
authors.affiliation: Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
authors.forename: Masayuki
authors.initials: M
authors.lastname: Kitano
authors.affiliation: 2nd Department of Internal Medicine , Osaka Medical College, Osaka, Japan.
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Higuchi
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001660:Biliary Tract Diseases / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery*; D001662:Biliary Tract Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D001707:Biopsy, Needle; D002758:Cholangiography / Q000295:instrumentation* / Q000379:methods; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000379:methods; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D007564:Japan; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D011237:Predictive Value of Tests; D011446:Prospective Studies; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D016896:Treatment Outcome
keywords: SpyGlass; cholangioscope; cholangioscopy; endoscopic retrograde cholangiopancreatography; peroral cholangioscopy