title: Classification of probe-based confocal laser endomicroscopy findings in pancreaticobiliary strictures.
abstract: OBJECTIVE
  The accurate diagnosis of indeterminate pancreaticobiliary strictures presents a clinical dilemma. Probe-based confocal laser endomicroscopy (pCLE) offers real-time in vivo microscopic tissue examination that may increase sensitivity for the detection of malignancy. the objective of this study was to develop and validate a standard descriptive classification of pcle in the pancreaticobiliary system.
  
  
  METHODS
  A total of 102 patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) with pCLE to assess indeterminate pancreaticobiliary strictures were enrolled in a multicenter registry; 89 of these patients were evaluable. Information and data on the following were collected prospectively: clinical, ERCP, tissue sampling, pCLE, and follow-up. A uniform classification of pCLE findings ("Miami Classification") was developed, consisting of a set of image interpretation criteria. Thereafter, these criteria were tested through blinded consensus review of 112 randomized pCLE videos from 47 patients, and inter-observer variability was assessed in 42 patients .
  
  
  RESULTS
  A consensus definition of the specific criteria of biliary and pancreatic pCLE findings for indeterminate strictures was developed. Single-image interpretation criteria did not have a high enough sensitivity for predicting malignancy. However, combining two or more criteria significantly increased the sensitivity and predictive values. The characteristics most suggestive of malignancy included the following: thick white bands (>20 µm), or thick dark bands (>40 µm), or dark clumps or epithelial structures. These provided sensitivity, specificity, positive predictive value, and negative predictive value of 97%, 33%, 80%, and 80% compared with 48%, 100%, 100%, and 41% for standard tissue sampling methods. Inter-observer variability was moderate for most criteria.
  
  
  CONCLUSIONS
  The Miami Classification enables a structured, uniform, and reproducible description of pancreaticobiliary pCLE. Combining individual characteristics improves the sensitivity for the detection of malignancy.
authors.affiliation: Klinikum rechts der Isar, Munich, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Meining
authors.forename: R J
authors.initials: RJ
authors.lastname: Shah
authors.forename: A
authors.initials: A
authors.lastname: Slivka
authors.forename: D
authors.initials: D
authors.lastname: Pleskow
authors.forename: R
authors.initials: R
authors.lastname: Chuttani
authors.forename: P D
authors.initials: PD
authors.lastname: Stevens
authors.forename: V
authors.initials: V
authors.lastname: Becker
authors.forename: Y K
authors.initials: YK
authors.lastname: Chen
mesh_terms: D000230:Adenocarcinoma / Q000150:complications / Q000175:diagnosis*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001649:Bile Duct Diseases / Q000145:classification / Q000209:etiology; D001650:Bile Duct Neoplasms / Q000150:complications / Q000175:diagnosis*; D001653:Bile Ducts, Intrahepatic / Q000473:pathology*; D018281:Cholangiocarcinoma / Q000150:complications / Q000175:diagnosis*; D002760:Cholangiopancreatography, Endoscopic Retrograde; D003251:Constriction, Pathologic / Q000145:classification / Q000209:etiology / Q000473:pathology; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000150:complications / Q000175:diagnosis*; D008297:Male; D018613:Microscopy, Confocal; D008875:Middle Aged; D015588:Observer Variation; D010182:Pancreatic Diseases / Q000145:classification / Q000209:etiology; D010183:Pancreatic Ducts / Q000473:pathology*; D010190:Pancreatic Neoplasms / Q000150:complications / Q000175:diagnosis*; D011237:Predictive Value of Tests