一种新型信号传输胶囊内镜与现有胶囊内镜的多中心、前瞻性、随机比较。
A multicenter, prospective, randomized comparison of a novel signal transmission capsule endoscope to an existing capsule endoscope.
机构信息
Division of Gastroenterology and Hepatology, Riverside Medical Clinic, Riverside, California, USA.
出版信息
Gastrointest Endosc. 2013 Aug;78(2):325-32. doi: 10.1016/j.gie.2013.02.039. Epub 2013 May 7.
BACKGROUND
MiroCam, a capsule endoscope, uses a novel transmission technology, electric-field propagation, which uses the human body as a conduction medium for data transmission.
OBJECTIVE
To compare the ability of the MiroCam (MC) and PillCam (PC) to identify sources of obscure GI bleeding (OGIB).
DESIGN
Prospective, multicenter, comparative study.
SETTING
Six academic hospitals.
PATIENTS
A total of 105 patients with OGIB.
INTERVENTION
Patients ingested both the MC and PC capsules sequentially in a randomized fashion.
MAIN OUTCOME MEASUREMENTS
Concordance of rates in identifying a source of OGIB, operational times, and rates of complete small-bowel examination.
RESULTS
Data analysis resulted in 43 (48%) "abnormal" cases identifying a source of OGIB by either capsule. Twenty-four cases (55.8%) were positive by both capsules. There was negative agreement in 46 of 58 cases (79.3%). The κ index was 0.547 (χ(2) = 1.32; P = .36). In 12 cases, MC positively identified a source that was not seen on PC, whereas in 7 cases, PC positively identified a source that was not seen on MC. MC had a 5.6% higher rate of detecting small-bowel lesions (P = .54). MC captured images at 3 frames per second for 11.1 hours, and PC captured images at 2 frames per second for 7.8 hours (P < .0001). Complete small-bowel examination was achieved in 93.3% for MC and 84.3% for PC (P = .10).
LIMITATIONS
Readers were not blinded to the particular capsule they were reading.
CONCLUSION
A positive diagnostic finding for OGIB was identified by either capsule in 48% of cases. The concordance rate between the 2 capsules was comparable to that of prior studies in identifying sources of small-bowel bleeding. The longer operational time of the MC may result in higher rates of complete small-bowel examination, which may, in turn, translate into a higher rate of detecting small-bowel lesions. (
CLINICAL TRIAL REGISTRATION NUMBER
NCT00878982.).
背景
MiroCam 胶囊内镜采用了一种新颖的传输技术——电场传播，该技术利用人体作为数据传输的传导介质。
目的
比较 MiroCam（MC）和 PillCam（PC）胶囊对不明原因胃肠道出血（OGIB）的源识别能力。
设计
前瞻性、多中心、对比研究。
地点
六所学术医院。
患者
共 105 例 OGIB 患者。
干预
患者以随机的方式先后吞下 MC 和 PC 胶囊。
主要观察指标
识别 OGIB 源的率、操作时间和完整小肠检查的率的一致性。
结果
数据分析显示，43 例（48%）“异常”病例通过任一胶囊都能识别出 OGIB 的源。24 例（55.8%）两种胶囊均为阳性。58 例中有 46 例（79.3%）为阴性一致。κ 指数为 0.547（χ²=1.32，P=0.36）。在 12 例中，MC 阳性识别到 PC 未检测到的源，而在 7 例中，PC 阳性识别到 MC 未检测到的源。MC 检测小肠病变的阳性率高 5.6%（P=0.54）。MC 每秒 3 帧的图像采集时间为 11.1 小时，PC 每秒 2 帧的图像采集时间为 7.8 小时（P<0.0001）。MC 完全小肠检查的完成率为 93.3%，PC 为 84.3%（P=0.10）。
局限性
读者对他们正在阅读的特定胶囊没有盲法。
结论
两种胶囊均能在 48%的病例中识别出 OGIB 的阳性诊断结果。两种胶囊在识别小肠出血源方面的一致性与之前的研究相当。MC 较长的操作时间可能会导致更高的完全小肠检查完成率，这可能会继而提高检测小肠病变的阳性率。（临床试验注册号：NCT00878982）。
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