Open Access
Endosc Int Open 2016; 04(08): E878-E882
DOI: 10.1055/s-0042-111389
Original article
© Georg Thieme Verlag KG Stuttgart · New York

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

Naoki Hosoe
1   Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan
,
Kenji Watanabe
2   Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan
,
Takako Miyazaki
2   Department of Gastroenterology, Osaka City University Graduate School of Medicine, Osaka, Japan
,
Masaaki Shimatani
3   Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan
,
Takahiro Wakamatsu
3   Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan
,
Kazuichi Okazaki
3   Third Department of Internal Medicine, Kansai Medical University, Osaka, Japan
,
Motohiro Esaki
4   Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
,
Takayuki Matsumoto
5   Division of Gastroenterology, Department of Internal Medicine, School of Medicine, Iwate Medical University, Morioka, Japan
,
Takayuki Abe
6   Department of Preventive Medicine and Public Health, Biostatistics at Center for Clinical Research, Keio University School of Medicine, Tokyo, Japan
,
Takanori Kanai
7   Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
,
Kazuo Ohtsuka
8   Department of Gastroenterology, School of Medicine, Tokyo Medical and Dental University, Tokyo, Japan
,
Mamoru Watanabe
8   Department of Gastroenterology, School of Medicine, Tokyo Medical and Dental University, Tokyo, Japan
,
Keiichi Ikeda
9   Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan
,
Hisao Tajiri
9   Department of Endoscopy, The Jikei University School of Medicine, Tokyo, Japan
,
Naoki Ohmiya
10   Department of Gastroenterology, School of Medicine, Fujita Health University, Aichi, Japan
,
Masanao Nakamura
11   Department of Gastroenterology, Nagoya Graduate School of Medicine, Nagoya, Japan
,
Hidemi Goto
11   Department of Gastroenterology, Nagoya Graduate School of Medicine, Nagoya, Japan
,
Tomoyuki Tsujikawa
12   Comprehensive Internal Medicine, Shiga University of Medical Science, Shiga, Japan
,
Haruhiko Ogata
1   Center for Diagnostic and Therapeutic Endoscopy, School of Medicine, Keio University, Tokyo, Japan
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Weitere Informationen

Publikationsverlauf

submitted28. Dezember 2015

accepted after revision13. Juni 2016

Publikationsdatum:
08. August 2016 (online)

Preview

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.