Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, China.
Dig Endosc. 2020 May;32(4):557-564. doi: 10.1111/den.13520. Epub 2019 Oct 10.
To compare feasibility and safety after gastrointestinal checkup by standing-type magnetically controlled capsule endoscopy (SMCE) and conventional gastroscopy.
This was a prospective multicenter, blinded study that compared SMCE with gastroscopy in patients from April 2018 to July 2018. All patients first underwent SMCE and then subsequently had gastroscopy with i.v. anesthesia. We calculated the compliance rates of gastric lesion detection by SMCE using gastroscopy as the standard. Capsule retention rate, incidence of adverse events, and patient satisfaction were documented throughout the study.
One hundred and sixty-one patients who completed SMCE and gastroscopy were included in the analysis. Positive compliance rate among SMCE and gastroscopy was 92.0% (95% CI: 80.77%-97.78%). Negative compliance rate was 95.5% (89.80%, 98.52%). Moreover, overall compliance rate was 94.41% (89.65%, 97.41%). Sixty-four pathological outcomes were identified. Of these 64 outcomes, 50 were detected by both procedures. The gastroscopy method neglected seven findings (such as five erosions, one polyp, and one ulcer). Furthermore, SMCE also overlooked seven lesions (i.e. one erosion, two polyps, one atrophy, and three submucosal tumors). Capsule retention or related adverse events were not reported.
Standing-type magnetically controlled capsule endoscopy provides equivalent agreement with gastroscopy and may be useful for screening of gastric illnesses without any anesthesia.
比较站立式磁控胶囊内镜(SMCE)与传统胃镜检查胃肠道后的可行性和安全性。
这是一项前瞻性多中心、盲法研究,比较了 2018 年 4 月至 7 月期间患者接受 SMCE 和胃镜检查的情况。所有患者均先接受 SMCE 检查,然后再进行静脉麻醉下的胃镜检查。我们根据胃镜检查结果计算了 SMCE 检测胃病变的符合率。记录了胶囊滞留率、不良事件发生率和患者满意度。
共有 161 例完成 SMCE 和胃镜检查的患者纳入分析。SMCE 和胃镜检查的阳性符合率为 92.0%(95%CI:80.77%-97.78%)。阴性符合率为 95.5%(89.80%,98.52%)。此外,总体符合率为 94.41%(89.65%,97.41%)。共发现 64 个病理结果。其中,两种方法均发现 50 个结果。胃镜检查方法漏诊了 7 个发现(如 5 个糜烂、1 个息肉和 1 个溃疡)。此外,SMCE 还忽略了 7 个病变(即 1 个糜烂、2 个息肉、1 个萎缩和 3 个黏膜下肿瘤)。未报告胶囊滞留或相关不良事件。
站立式磁控胶囊内镜与胃镜检查具有同等的一致性,可用于无需麻醉的胃部疾病筛查。