title: SpyGlass single-operator peroral cholangioscopy in the evaluation of indeterminate biliary lesions: a single-center, prospective, cohort study.
abstract: BACKGROUND
  SpyGlass single-operator peroral cholangioscopy appears to be a promising technique to overcome some limitations of conventional peroral cholangioscopy. We aimed to prospectively evaluate the SpyGlass system in a cohort of patients with indeterminate biliary lesions.
  
  
  METHODS
  Patients with indeterminate strictures or filling defects at endoscopic retrograde cholangiopancreatography (ERCP) were consecutively enrolled. After SpyGlass visual evaluation, targeted biopsies were taken with the SpyBite and histopathological assessment was made by two experienced gastrointestinal pathologists. SpyBite-targeted biopsy results were evaluated by assessing agreement with surgical specimens and by evaluation of final, clinical follow-up-based diagnosis.
  
  
  RESULTS
  Fifty-two patients participated in the study. In 7 cases, definite diagnosis (stones, varices) was made by SpyGlass endoscopic evaluation. In 42 of the remaining 45 cases, material suitable for histopathology assessment was provided by the SpyBite. Overall, a definite diagnosis was made in 49 (7 + 42; 94 %) cases. Agreement of SpyBite biopsy results with surgical specimen diagnosis was found in 38/42 (90 %) cases; sensitivity, specificity, and positive and negative predictive values were 88, 94, 96, and 85 %, respectively. Procedure-related complications consisted of one case of mild cholangitis and one case of mild pancreatitis.
  
  
  CONCLUSIONS
  In our series, the SpyGlass system allowed adequate biopsy sampling and definite diagnosis with high accuracy in the vast majority of patients with indeterminate biliary lesions. Its use was associated with a low complication rate. Further refinements of the technique are warranted, but the SpyGlass system has the potential to become a diagnostic standard for the assessment of indeterminate biliary lesions.
authors.affiliation: Gastroenterologia ed Endoscopia Digestiva, Nuovo Ospedale S. Agostino, Viale Giardini 1355, 41100 Modena, Italy. r.manta@libero.it
authors.forename: Raffaele
authors.initials: R
authors.lastname: Manta
authors.forename: Marzio
authors.initials: M
authors.lastname: Frazzoni
authors.forename: Rita
authors.initials: R
authors.lastname: Conigliaro
authors.forename: Livia
authors.initials: L
authors.lastname: Maccio
authors.forename: Gianlugi
authors.initials: G
authors.lastname: Melotti
authors.forename: Emanuele
authors.initials: E
authors.lastname: Dabizzi
authors.forename: Helga
authors.initials: H
authors.lastname: Bertani
authors.forename: Mauro
authors.initials: M
authors.lastname: Manno
authors.forename: Danilo
authors.initials: D
authors.lastname: Castellani
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Villanacci
authors.forename: Gabrio
authors.initials: G
authors.lastname: Bassotti
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001660:Biliary Tract Diseases / Q000175:diagnosis* / Q000473:pathology / Q000601:surgery; D001661:Biliary Tract Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000601:surgery; D001706:Biopsy / Q000295:instrumentation; D018281:Cholangiocarcinoma / Q000175:diagnosis / Q000473:pathology / Q000601:surgery; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002761:Cholangitis / Q000209:etiology; D019723:Endoscopes; D016145:Endoscopy, Digestive System / Q000009:adverse effects / Q000295:instrumentation*; D005260:Female; D005706:Gallbladder Neoplasms / Q000175:diagnosis / Q000473:pathology / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D010190:Pancreatic Neoplasms / Q000473:pathology; D010195:Pancreatitis / Q000209:etiology; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D015607:Stents