Akira Dobashi1,2, Kenichi Goda3,4, Hiroto Furuhashi3, Hiroaki Matsui3, Yuko Hara3, Shunsuke Kamba3, Masakuni Kobayashi3, Kazuki Sumiyama3, Shinichi Hirooka5, Shigeharu Hamatani5, Elizabeth Rajan6, Masahiro Ikegami5, Hisao Tajiri7. 1. Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan. akira.dobashi1980@gmail.com. 2. Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA. akira.dobashi1980@gmail.com. 3. Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan. 4. Department of Gastroenterology, Dokkyo Medical University, Mibu, Japan. 5. Department of Pathology, The Jikei University School of Medicine, Tokyo, Japan. 6. Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA. 7. Department of Innovative Interventional Endoscopy Research, The Jikei University School of Medicine, Tokyo, Japan.
Abstract
BACKGROUND: Our previous studies have shown the diagnostic utility of a newly developed dual-focus endoscope with narrow-band imaging (DF-NBI) and simplified dyad criteria for detection of superficial esophageal squamous cell carcinoma (SESCC). This clinical trial aimed to study the diagnostic efficacy of DF-NBI with dyad criteria for detecting SESCC compared to white light imaging (WLI). METHODS: This was a single-arm prospective comparative trial. We enrolled 170 consecutive high-risk patients for esophageal squamous cell carcinoma. Patients were initially examined with WLI by one independent endoscopist and then the other performed DF-NBI blinded to the WLI diagnosis to avoid a carry-over effect. Lesions showing proliferation and/or various shapes of intrapapillary capillary loops (IPCL) under DF-NBI (i.e., dyad criteria) were endoscopically diagnosed as SESCC including high-grade intraepithelial neoplasia. The primary endpoint was sensitivity of WLI and DF-NBI for detecting SESCC. The secondary endpoints were the diagnostic performance (i.e., specificity and accuracy) and inter/intra-observer concordance of DF-NBI with dyad criteria. RESULTS: A total 77 SESCCs were detected. The sensitivity of DF-NBI for SESCC was significantly higher than that of WLI (91% vs. 51%, P < 0.001). The specificity and accuracy of WLI and DF-NBI using dyad criteria were 100% vs. 84%, and 86% vs. 86%, respectively. Various shapes and proliferation of IPCL showed the highest value in inter-observer and intra-observer agreements (κ = 0.77 and 0.82, respectively). CONCLUSION: DF-NBI combined with dyad criteria may be a promising technique with a high sensitivity for diagnosis of SESCC and high inter/intra-observer agreement.
RCT Entities:
BACKGROUND: Our previous studies have shown the diagnostic utility of a newly developed dual-focus endoscope with narrow-band imaging (DF-NBI) and simplified dyad criteria for detection of superficial esophageal squamous cell carcinoma (SESCC). This clinical trial aimed to study the diagnostic efficacy of DF-NBI with dyad criteria for detecting SESCC compared to white light imaging (WLI). METHODS: This was a single-arm prospective comparative trial. We enrolled 170 consecutive high-risk patients for esophageal squamous cell carcinoma. Patients were initially examined with WLI by one independent endoscopist and then the other performed DF-NBI blinded to the WLI diagnosis to avoid a carry-over effect. Lesions showing proliferation and/or various shapes of intrapapillary capillary loops (IPCL) under DF-NBI (i.e., dyad criteria) were endoscopically diagnosed as SESCC including high-grade intraepithelial neoplasia. The primary endpoint was sensitivity of WLI and DF-NBI for detecting SESCC. The secondary endpoints were the diagnostic performance (i.e., specificity and accuracy) and inter/intra-observer concordance of DF-NBI with dyad criteria. RESULTS: A total 77 SESCCs were detected. The sensitivity of DF-NBI for SESCC was significantly higher than that of WLI (91% vs. 51%, P < 0.001). The specificity and accuracy of WLI and DF-NBI using dyad criteria were 100% vs. 84%, and 86% vs. 86%, respectively. Various shapes and proliferation of IPCL showed the highest value in inter-observer and intra-observer agreements (κ = 0.77 and 0.82, respectively). CONCLUSION:DF-NBI combined with dyad criteria may be a promising technique with a high sensitivity for diagnosis of SESCC and high inter/intra-observer agreement.
Authors: C T Lee; C Y Chang; Y C Lee; C M Tai; W L Wang; P H Tseng; J C Hwang; T Z Hwang; C C Wang; J T Lin Journal: Endoscopy Date: 2010-07-28 Impact factor: 10.093