title: Narrow-band imaging vs. high definition white light for optical diagnosis of small colorectal polyps: a randomized multicenter trial.
abstract: OBJECTIVE
  The aim of the study was to compare the latest narrow-band imaging (NBI) device with high-definition white light (HDWL) endoscopy for accuracy of real-time optical diagnosis of small colorectal polyps.
  
  
  METHODS
  We conducted a randomized, prospective, multicenter trial at three study sites in Germany. In the NBI arm, endoscopists used NBI for the prediction of polyp pathology on the basis of the NBI International Colorectal Endoscopic classification. In the HDWL arm, NBI was not used for optical classification of polyp histology. The primary outcome was accuracy of optical diagnoses (neoplastic vs. non-neoplastic) in small polyps measuring < 10 mm. Secondary end points included sensitivity and negative predictive value (NPV).
  
  
  RESULTS
  A total of 380 patients were randomized 1:1 to either the NBI or HDWL arm. A total of 421 polyps measuring < 10 mm were detected (55.8 % neoplastic, 44.2 % non-neoplastic). Accuracy, sensitivity, and NPV were 73.7 %, 82.4 %, and 75.5 %, respectively, in the NBI arm and 79.2 %, 79.8 %, and 73.4 %, respectively, in the HDWL arm (P = 0.225, P = 0.667, P = 0.765). More polyps were assessed with high confidence in the HDWL arm (82.6 %) than in the NBI arm (73.7 %; P = 0.038). The NPV of the prediction of neoplastic histology in diminutive polyps (≤ 5 mm) rated with high confidence was 90.3 % in the NBI arm. We detected significant differences between the participating study sites in the performance data of predictions.
  
  
  CONCLUSIONS
  The levels of accuracy for real-time prediction of polyp histology (< 10 mm) did not differ between NBI and HDWL for optical diagnosis. Variation in the performance of optical diagnosis was apparent between study centers.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT02009774).
authors.affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Klare
authors.affiliation: Institut für Medizinische Statistik und Epidemiologie, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Haller
authors.affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
authors.forename: Sandra
authors.initials: S
authors.lastname: Wormbt
authors.affiliation: Innere Medizin I, Sana Klinikum Lichtenberg, Berlin, Germany.
authors.forename: Ellen
authors.initials: E
authors.lastname: Nötzel
authors.affiliation: Innere Medizin I, Sana Klinikum Lichtenberg, Berlin, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Hartmann
authors.affiliation: Medizinische Klinik 1, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Albert
authors.affiliation: Medizinische Klinik 1, Universitätsklinikum Frankfurt, Frankfurt am Main, Germany.
authors.forename: Johannes
authors.initials: J
authors.lastname: Hausmann
authors.affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
authors.forename: Henrik
authors.initials: H
authors.lastname: Einwächter
authors.affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Weber
authors.affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abdelhafez
authors.affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
authors.forename: Roland M
authors.initials: RM
authors.lastname: Schmid
authors.affiliation: II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: von Delius
mesh_terms: D000328:Adult; D000368:Aged; D001706:Biopsy / Q000379:methods / Q000592:standards; D003111:Colonic Polyps / Q000175:diagnosis / Q000000981:diagnostic imaging / Q000473:pathology; D003113:Colonoscopy / Q000379:methods / Q000592:standards; D057186:Comparative Effectiveness Research; D003951:Diagnostic Errors / Q000517:prevention & control*; D061827:Dimensional Measurement Accuracy; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D062048:Narrow Band Imaging / Q000379:methods / Q000592:standards; D011237:Predictive Value of Tests; D014172:Transillumination / Q000379:methods / Q000592:standards; D047368:Tumor Burden