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Endosc Int Open. 2016 Aug;4(8):E878-82. doi: 10.1055/s-0042-111389. Epub 2016 Aug 08.

Evaluation of performance of the Omni mode for detecting video capsule endoscopy images: A multicenter randomized controlled trial.

Endoscopy international open

Naoki Hosoe, Kenji Watanabe, Takako Miyazaki, Masaaki Shimatani, Takahiro Wakamatsu, Kazuichi Okazaki, Motohiro Esaki, Takayuki Matsumoto, Takayuki Abe, Takanori Kanai, Kazuo Ohtsuka, Mamoru Watanabe, Keiichi Ikeda, Hisao Tajiri, Naoki Ohmiya, Masanao Nakamura, Hidemi Goto, Tomoyuki Tsujikawa, Haruhiko Ogata

Affiliations

  1. Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan.
  2. Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan.
  3. Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan.
  4. Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
  5. Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Morioka, Japan.
  6. Department of Preventive Medicine and Public Health, Biostatistics at Center for Clinical Research, Keio University School of Medicine, Tokyo, Japan.
  7. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.
  8. Department of Gastroenterology, School of Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
  9. Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan.
  10. Department of Gastroenterology, School of Medicine, Fujita Health University, Aichi, Japan.
  11. Department of Gastroenterology, Nagoya Graduate School of Medicine, Nagoya, Japan.
  12. Comprehensive Internal Medicine, Shiga University of Medical Science, Shiga, Japan.

PMID: 27540577 PMCID: PMC4988834 DOI: 10.1055/s-0042-111389

Abstract

BACKGROUND AND STUDY AIMS: Olympus recently developed a new algorithm called Omni mode that discards redundant video capsule endoscopy (VCE) images. The current study aimed to demonstrate the non-inferiority of the Omni mode in terms of true positives (TPs) and the superiority of the Omni mode with regard to reading time against a control (ordinary ES-10 system).

PATIENTS AND METHODS: This multicenter prospective study included 40 patients with various small bowel diseases. VCE images were evaluated by 7 readers and 3 judging committee members. Two randomly allocated readers assessed the VCE images obtained using the 2 modalities for each patient. The order of the modalities was switched between the 2 readers and the interval between readings by the same reader was 2 weeks. The judging committee predefined clinically relevant lesions as major lesions and irrelevant lesions as minor lesions. The number of TPs for major and minor lesions and the reading times were compared between the modalities. The predefined non-inferiority margin for the TP ratio of the Omni mode compared with the control was 0.9.

RESULTS: The estimated TP ratios and 95 % confidence intervals for total, major, and minor lesions were 0.87 (0.80 - 0.95), 0.93 (0.83 - 1.04), and 0.83 (0.74 - 0.94), respectively. Although non-inferiority was not demonstrated, the rate of detection of major lesions was not significantly different between the modalities. The reading time was significantly lower when using the Omni mode than when using the control.

CONCLUSIONS: The Omni mode may be only appropriate for the assessment of major lesions.

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