Cave David R, Fleischer David E, Leighton Jonathan A, Faigel Douglas O, Heigh Russell I, Sharma Virender K, Gostout Christopher J, Rajan Elizabeth, Mergener Klaus, Foley Anne, Lee Michael, Bhattacharya Kanishka
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, USA.
Gastrointest Endosc. 2008 Sep;68(3):487-94. doi: 10.1016/j.gie.2007.12.037. Epub 2008 Apr 14.
Video capsule endoscopy has been shown to be the single most effective endoscopic procedure for identifying the source of obscure GI bleeding (OGIB).
Our purpose was to report on the Food and Drug Administration pivotal trial in which the Endocapsule (EC) (Olympus America, Allentown, Pa) was compared with the Pillcam SB (PSB) (Given Imaging, Yoqneam, Israel) in patients with OGIB.
A novel trial design was used in which the EC and the PSB were swallowed by the same patient 40 minutes apart, in randomized order.
Four academic medical centers.
Patients with OGIB aged 18 to 85 years who had either been transfused or who had a hematocrit of <31% in males or <28% in females.
Both video capsules were swallowed in random order. Videos from the PSB were read locally for patient management. All videos were then read by at least 2 independent readers for normal versus abnormal categorization, a diagnosis, capsule transit time, reading time, and a subjective assessment of image quality.
Categorization of videos as either normal or abnormal.
Data from 51 of 63 enrolled patients were analyzed. Nine patients were excluded for technical reasons and 3 for protocol violations. Twenty-four videos were read as normal and 14 as abnormal from both capsules. Disagreement occurred in 13. No adverse events were reported for either capsule. Overall agreement was 38 of 51 (74.5%) with a kappa of 0.48, P = .008.
Although ingestion order was randomized, the videos could not be read blind owing to a different shape of the image margin.
(1) Both devices were safe and had a comparable diagnostic yield within the range previously reported. (2) There was a subjective difference in image quality favoring the EC. (3) This study design provided unique information about capsule movement in the small intestine and the lack of electromechanical interference between 2 different capsules.
视频胶囊内镜已被证明是识别不明原因胃肠道出血（OGIB）来源的最有效的单一内镜检查方法。
我们的目的是报告美国食品药品监督管理局的关键试验，该试验将Endocapsule（EC）（奥林巴斯美国公司，宾夕法尼亚州阿伦敦）与Pillcam SB（PSB）（Given Imaging公司，以色列约克尼姆）用于OGIB患者进行比较。
采用了一种新颖的试验设计，让同一患者以随机顺序间隔40分钟分别吞下EC和PSB。
四个学术医疗中心。
年龄在18至85岁之间、接受过输血或男性血细胞比容<31%或女性血细胞比容<28%的OGIB患者。
两种视频胶囊均以随机顺序吞下。PSB的视频在当地用于患者管理。然后所有视频由至少2名独立阅片者进行阅片，以进行正常与异常分类、诊断、胶囊通过时间、阅片时间以及图像质量的主观评估。
将视频分类为正常或异常。
分析了63名入组患者中51名患者的数据。9名患者因技术原因被排除，3名患者因违反方案被排除。两种胶囊的24个视频被读为正常，14个视频被读为异常。13个视频存在分歧。两种胶囊均未报告不良事件。总体一致性为51例中的38例（74.5%），kappa值为0.48，P = 0.008。
尽管摄入顺序是随机的，但由于图像边缘形状不同，视频无法盲法阅片。
（1）两种设备均安全，且诊断率在先前报告的范围内具有可比性。（2）在图像质量方面存在主观差异，EC更具优势。（3）本研究设计提供了关于胶囊在小肠内运动以及两种不同胶囊之间不存在机电干扰的独特信息。
