title: Validation of the diagnostic accuracy of probe-based confocal laser endomicroscopy for the characterization of indeterminate biliary strictures: results of a prospective multicenter international study.
abstract: BACKGROUND
  Characterization of indeterminate biliary strictures remains problematic. Tissue sampling is the criterion standard for confirming malignancy but has low sensitivity. Probe-based confocal laser endomicroscopy (pCLE) showed excellent sensitivity in a registry; however, it has not been validated in a prospective study.
  
  
  OBJECTIVE
  To prospectively validate pCLE in real time during ERCP for indeterminate biliary strictures.
  
  
  METHODS
  Prospective, international, multicenter study.
  
  
  METHODS
  Six academic centers.
  
  
  METHODS
  A total of 136 patients with indeterminate biliary strictures.
  
  
  METHODS
  Investigators provided a presumptive diagnosis based on the patient history, ERCP impression, and pCLE during the procedure before and after tissue sampling results were available. A presumptive diagnosis also was made separately by a blinded investigator during ERCP and after tissue sampling to estimate care without pCLE. Follow-up was at least 6 months.
  
  
  METHODS
  Accuracy, sensitivity, and specificity during ERCP alone, ERCP with pCLE, and ERCP with pCLE and tissue sampling.
  
  
  RESULTS
  A total of 112 patients were evaluated (71 with malignant lesions). Tissue sampling alone was 56% sensitive, 100% specific, and 72% (95% confidence interval [CI], 63%-80%) accurate. pCLE with ERCP was 89% sensitive, 71% specific, and 82% (95% CI, 74%-89%) accurate. After tissue sampling returned, strictures could be characterized with 88% (95% CI, 81%-94%) accuracy.
  
  
  CONCLUSIONS
  No randomization of care maps. pCLE not blinded.
  
  
  CONCLUSIONS
  pCLE provided a more accurate and sensitive diagnosis of cholangiocarcinoma compared with tissue sampling alone. Incorporation of pCLE into the diagnostic armamentarium of patients with indeterminate biliary strictures may allow for a more accurate assessment, potentially reducing delays in diagnosis and costly repeat testing. (
  
  
  BACKGROUND
  NCT01392274.).
authors.affiliation: Division of Gastroenterology, Hepatology & Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
authors.forename: Adam
authors.initials: A
authors.lastname: Slivka
authors.affiliation: Digestive Disease Institute, Gastroenterology and Hepatology Colorectal cancer, Virginia Mason Bellevue Clinic, Seattle, Washington, USA.
authors.forename: Ian
authors.initials: I
authors.lastname: Gan
authors.affiliation: Section of Digestive Diseases, New Haven, Connecticut, USA.
authors.forename: Priya
authors.initials: P
authors.lastname: Jamidar
authors.affiliation: Ambulatorio di Endoscopia e Fisiopatologia Digestiva Chirurgica, Policlinico Policlinico Universitario Agostino Gemelli, Roma, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Costamagna
authors.affiliation: Ambulatorio di Endoscopia e Fisiopatologia Digestiva Chirurgica, Policlinico Policlinico Universitario Agostino Gemelli, Roma, Italy.
authors.forename: Paola
authors.initials: P
authors.lastname: Cesaro
authors.affiliation: Service d'Endoscopie, Institut Paoli Calmettes, Marseille, France.
authors.forename: Marc
authors.initials: M
authors.lastname: Giovannini
authors.affiliation: Service d'Endoscopie, Institut Paoli Calmettes, Marseille, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Caillol
authors.affiliation: Division of Gastroenterology & Hepatology, Weill Cornell Medical College, New York, New York, USA.
authors.forename: Michel
authors.initials: M
authors.lastname: Kahaleh
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001650:Bile Duct Neoplasms / Q000150:complications / Q000175:diagnosis*; D001653:Bile Ducts, Intrahepatic; D018281:Cholangiocarcinoma / Q000150:complications / Q000175:diagnosis*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D002779:Cholestasis / Q000000981:diagnostic imaging / Q000209:etiology* / Q000473:pathology; D003251:Constriction, Pathologic; D005260:Female; D006801:Humans; D008297:Male; D018613:Microscopy, Confocal; D008875:Middle Aged; D011446:Prospective Studies; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity