title: Endoscopic optical diagnosis provides high diagnostic accuracy of esophageal squamous cell carcinoma.
abstract: BACKGROUND
  Recent technological advances have stimulated the development of endoscopic optical biopsy technologies. This study compared the accuracy of endoscopic diagnosis using magnifying narrow-band imaging (NBI) and histologic diagnosis of esophageal squamous lesions.
  
  
  METHODS
  Patients at high risk for esophageal squamous cell carcinoma were examined with endoscopy and subsequent biopsy. The lesions diagnosed as cancer on NBI and the lesions diagnosed as cancer on biopsy were resected endoscopically or surgically. Histological diagnoses of resected specimens, the reference standards in this study, were made by a pathologist who was blind to both the endoscopic and biopsy diagnoses. The primary outcome was the accuracy of endoscopic and biopsy diagnosis. A noninferiority trial design with a noninferiority margin of -10% was chosen to investigate the accuracy of endoscopic diagnosis using magnifying NBI.
  
  
  RESULTS
  Between November 2010 and October 2012, a total of 111 lesions in 85 patients were included in the analysis. The accuracy of endoscopic diagnosis and biopsy diagnosis for all lesions was 91.0% (101/111) and 85.6% (95/111), respectively. The difference in diagnostic accuracy was 5.4% (95% confidence interval: -2.9%-13.7%). The accuracy of endoscopic diagnosis and biopsy diagnosis of invasive cancers was 94.9% (74/78) and 84.6% (66/78), respectively. The difference was 10.3% (95% confidence interval: 1.6%-19.0%) for invasive cancers. The lower bound of the 95% confidence interval was above the prestated -10% in both cases.
  
  
  CONCLUSIONS
  Noninferiority of endoscopic diagnosis by magnifying NBI to histologic diagnosis by biopsy was established in this study (p = 0.0001).
  
  
  BACKGROUND
  The study was registered on 9th November 2010 in the University Hospital Medical Network Clinical Trials Registry as number: UMIN000004529.
authors.forename: Kengo
authors.initials: K
authors.lastname: Nagai
authors.affiliation: Departments of Gastrointestinal Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 3-3, Nakamichi 1-chome, Higashinari-ku, Osaka 537-8511, Japan. isihara-ry@mc.pref.osaka.jp.
authors.forename: Ryu
authors.initials: R
authors.lastname: Ishihara
authors.forename: Shingo
authors.initials: S
authors.lastname: Ishiguro
authors.forename: Takashi
authors.initials: T
authors.lastname: Ohta
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kanzaki
authors.forename: Takeshi
authors.initials: T
authors.lastname: Yamashina
authors.forename: Kenji
authors.initials: K
authors.lastname: Aoi
authors.forename: Noriko
authors.initials: N
authors.lastname: Matsuura
authors.forename: Takashi
authors.initials: T
authors.lastname: Ito
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Fujii
authors.forename: Sachiko
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Noboru
authors.initials: N
authors.lastname: Hanaoka
authors.forename: Yoji
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Koji
authors.initials: K
authors.lastname: Higashino
authors.forename: Noriya
authors.initials: N
authors.lastname: Uedo
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Iishi
authors.forename: Masaharu
authors.initials: M
authors.lastname: Tatsuta
authors.forename: Yasuhiko
authors.initials: Y
authors.lastname: Tomita
authors.forename: Takashi
authors.initials: T
authors.lastname: Matsunaga
mesh_terms: D001706:Biopsy; D002278:Carcinoma in Situ / Q000175:diagnosis* / Q000473:pathology; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis* / Q000473:pathology; D004938:Esophageal Neoplasms / Q000175:diagnosis* / Q000473:pathology; D000077277:Esophageal Squamous Cell Carcinoma; D004945:Esophagoscopy / Q000379:methods*; D006801:Humans; D062048:Narrow Band Imaging / Q000379:methods*; D012680:Sensitivity and Specificity
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