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采用磁导胶囊内窥镜与标准视频内窥镜行胃部检查的盲法非随机对照研究

发布日期:2014-1-29 12:40:30 文章来源:GIE 作者次数:1230
    采用磁导胶囊内窥镜与标准视频内窥镜行胃部检查的盲法非随机对照研究

    背景

    被动式视频胶囊內镜是小肠探查判断标准,但不能用于大胃腔。我们报道了第一例人类盲法对照临床试验,并对导胶囊内窥镜MGCE)和常规高清晰度胃镜进行了比较。

    目的

    评估采用一种被引导的胶囊镜行胃部检查的效果。

    设计

    盲法非随机对照研究。

    环境

    单內镜检查中心。

    方法

    本实验共61例患者参与到一项事先不知情的胶囊胃镜对比研究中。患者接受胃镜检查后24h,行磁导胶囊内窥镜(MGCE检查。为除去食物残渣或粘液,患者分两次喝掉900ml水。之后,为提供引导系统所需的空气水分界面,这些患者又喝了400ml35°C)。

    结果

    胃幽门,胃窦,胃体,胃底部,胃贲门的可视化分别在88.5%,86.9%,93.4%,85.2%和88.5%的患者中视为完整。在即时评估和对记录的数据进行审查时,胃镜检查与磁导胶囊内窥镜检查(MGCE均可检测出58.3%的胃部病变。胶囊检查遗漏了14MGCE所观察到的发现情况,同时胃镜遗漏了31处。这两种模式总体诊断率是相似的。

    局限性

    试点研究。

    结论

    两种方式的诊断结果是相似的。本研究攻克了一些与胃扩张或出现粘液有关的技术难题后,为由于胃癌发生率较高而需一项检查手段的国家开拓了一项新型无创性胃部检查技术。

     

    缩写词:MGCE,磁导胶囊内窥镜;MRI,磁共振成像。

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    Blinded nonrandomized comparative study of gastric examination with a magnetically guided capsule endoscope and standard videoendoscope

    Background

    Passive video capsule endoscopy is the criterion standard for small-bowel exploration but cannot be used for the large gastric cavity. We report the first blinded comparative clinical trial in humans comparing a magnetically guided capsule endoscope (MGCE) and a conventional high-definition gastroscope.

    Objective

    To assess the potential of gastric examination with a guided capsule.

    Design

    Blinded, nonrandomized comparative study.

    Setting

    Single endoscopy center.

    Methods

    The trial involved 61 patients included in a blinded capsule and gastroscopy comparative study. MGCE examination was performed 24 hours after patients had undergone gastroscopy. To remove food residue or mucus, patients drank 900 mL of water in 2 portions. Then to provide the air-water interface required by the guidance system, they drank 400 mL of water at 35°C.

    Results

    Visualization of the gastric pylorus, antrum, body, fundus, and cardia was evaluated as complete in 88.5%, 86.9%, 93.4%, 85.2%, and 88.5% of patients, respectively. Of gastric lesions, 58.3% were detected by both gastroscopy and MGCE at immediate assessment and review of recorded data. Capsule examination missed 14 findings and gastroscopy missed 31 findings seen with MGCE. Overall diagnostic yield was similar for both modalities.

    Limitation

    Pilot study.

    Conclusions

    Diagnostic results were similar for the 2 methods. After some technical difficulties related to gastric expansion or presence of mucus had been overcome, this study opened a new field for noninvasive gastric examination in countries where high gastric cancer incidence demands a screening tool.

    Abbreviations:  MGCE, magnetically guided capsule endoscope, MRI, magnetic resonance imaging

     

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