title: Multicenter, prospective trial of white-light imaging alone versus white-light imaging followed by magnifying endoscopy with narrow-band imaging for the real-time imaging and diagnosis of invasion depth in superficial esophageal squamous cell carcinoma.
abstract: BACKGROUND
  Magnifying endoscopy with narrow-band imaging (ME-NBI) has been used to estimate the invasion depth of superficial esophageal squamous cell carcinoma (SESCC), but the real diagnostic power of ME-NBI remains unclear because of few prospective studies.
  
  
  OBJECTIVE
  To evaluate whether ME-NBI adds additional information to white-light imaging (WLI) for the diagnosis of invasion depth of SESCC.
  
  
  METHODS
  Multicenter, prospective trial using real-time imaging and diagnosis.
  
  
  METHODS
  Seven Japanese institutions.
  
  
  METHODS
  Fifty-five patients with SESCC were enrolled from June 2011 to October 2013, and the results for 49 lesions were analyzed.
  
  
  METHODS
  Patients underwent primary WLI followed by ME-NBI, and reports of primary WLI (WLI alone) were completed before secondary ME-NBI (WLI followed by ME-NBI). To standardize diagnosis among examiners, this trial was started after achievement of a mean κ value≥.6 among 11 participating endoscopists.
  
  
  METHODS
  Diagnosis of invasion depth by each tool was divided into cancer limited to the epithelium and the lamina propria mucosa and cancer invading beyond the muscularis mucosae (≥T1a-MM) and then collated with the final pathologic diagnosis by an independent pathologist blinded to the clinical data.
  
  
  RESULTS
  The accuracy of invasion depth in WLI alone and WLI followed by ME-NBI was 71.4% and 65.3% (P=.375), respectively. Sensitivity for ≥T1a-MM was 61.1% for both groups (P=1.000), and specificity for ≥T1a-MM was 77.4% for WLI alone and 67.7% for WLI followed by ME-NBI (P=.375).
  
  
  CONCLUSIONS
  Open-label trial.
  
  
  CONCLUSIONS
  ME-NBI showed no additional benefit to WLI for diagnosis of invasion depth of SESCC. (University Hospital Network Clinical Trials Registry number: UMIN000005632.).
authors: Department of Gastroenterology and Metabolisms, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors: Masahide
authors: M
authors: Ebi
authors: Department of Gastroenterology and Metabolisms, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; Vascular Biology Program, Boston Children's Hospital, Boston, Massachusetts, USA; Department of Surgery, Harvard Medical School and Boston Children's Hospital, Boston, Massachusetts, USA.
authors: Takaya
authors: T
authors: Shimura
authors: Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
authors: Tomonori
authors: T
authors: Yamada
authors: Department of Gastroenterology, Gifu Prefectural Tajimi Hospital, Tajimi, Japan.
authors: Takashi
authors: T
authors: Mizushima
authors: Department of Gastroenterology, Nagoya City East Medical Center, Nagoya, Japan.
authors: Keisuke
authors: K
authors: Itoh
authors: Department of Gastroenterology and Metabolisms, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors: Hironobu
authors: H
authors: Tsukamoto
authors: Department of Gastroenterology, Nagoya City West Medical Center, Nagoya, Japan.
authors: Kenji
authors: K
authors: Tsuchida
authors: Department of Gastroenterology, Kasugai Municipal Hospital, Kasugai, Japan.
authors: Yoshikazu
authors: Y
authors: Hirata
authors: Department of Gastroenterology, Nagoya Memorial Hospital, Nagoya, Japan.
authors: Kenji
authors: K
authors: Murakami
authors: Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
authors: Hiroshi
authors: H
authors: Kanie
authors: Department of Gastroenterology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
authors: Satoshi
authors: S
authors: Nomura
authors: Department of Gastroenterology, Gifu Prefectural Tajimi Hospital, Tajimi, Japan.
authors: Hiroyasu
authors: H
authors: Iwasaki
authors: Department of Gastroenterology, Nagoya City East Medical Center, Nagoya, Japan.
authors: Mika
authors: M
authors: Kitagawa
authors: Department of Experimental Pathology and Tumor Biology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors: Satoru
authors: S
authors: Takahashi
authors: Department of Gastroenterology and Metabolisms, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
authors: Takashi
authors: T
authors: Joh
mesh_terms: D000368:Aged; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000473:pathology*; D004938:Esophageal Neoplasms / Q000175:diagnosis / Q000473:pathology*; D000077277:Esophageal Squamous Cell Carcinoma; D004945:Esophagoscopy / Q000379:methods*; D004947:Esophagus / Q000473:pathology*; D005260:Female; D006801:Humans; D008297:Male; D008853:Microscopy; D008875:Middle Aged; D009092:Mucous Membrane / Q000473:pathology*; D062048:Narrow Band Imaging; D009361:Neoplasm Invasiveness; D011446:Prospective Studies; D012680:Sensitivity and Specificity