Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai, China.
Department of Gastroenterology, General Hospital of Chinese People's Liberation Army, Beijing, China.
Clin Gastroenterol Hepatol. 2016 Sep;14(9):1266-1273.e1. doi: 10.1016/j.cgh.2016.05.013. Epub 2016 May 20.
BACKGROUND & AIMS: Diseases of the stomach, including gastric cancer and peptic ulcer, are the most common digestive diseases. It is impossible to visualize the entire stomach with the passive capsule currently used in practice because of the large size of the gastric cavity. A magnetically controlled capsule endoscopy (MCE) system has been designed to explore the stomach. We performed a prospective study to compare the accuracy of detection of gastric focal lesions by MCE vs conventional gastroscopy (the standard method).
We performed a multicenter blinded study comparing MCE with conventional gastroscopy in 350 patients (mean age, 46.6 y), with upper abdominal complaints scheduled to undergo gastroscopy at a tertiary center in China from August 2014 through December 2014. All patients underwent MCE, followed by conventional gastroscopy 2 hours later, without sedation. We calculated the sensitivity, specificity, positive predictive value, and negative predictive value of detection of gastric focal lesions by MCE, using gastroscopy as the standard.
MCE detected gastric focal lesions in the whole stomach with 90.4% sensitivity (95% confidence interval [CI], 84.7%-96.1%), 94.7% specificity (95% CI, 91.9%-97.5%), a positive predictive value of 87.9% (95% CI, 81.7%-94.0%), a negative predictive value of 95.9% (95% CI, 93.4%-98.4%), and 93.4% accuracy (95% CI, 90.83%-96.02%). MCE detected focal lesions in the upper stomach (cardia, fundus, and body) with 90.2% sensitivity (95% CI, 82.0%-98.4%) and 96.7% specificity (95% CI, 94.4%-98.9%). MCE detected focal lesions in the lower stomach (angulus, antrum, and pylorus) with 90.6% sensitivity (95% CI, 82.7%-98.4%) and 97.9% specificity (95% CI, 96.1%-99.7%). MCE detected 1 advanced gastric carcinoma, 2 malignant lymphomas, and 1 early stage gastric tumor. MCE did not miss any lesions of significance (including tumors or large ulcers). Among the 350 patients, 5 reported 9 adverse events (1.4%) and 335 preferred MCE over gastroscopy (95.7%).
MCE detects focal lesions in the upper and lower stomach with comparable accuracy with conventional gastroscopy. MCE is preferred by almost all patients, compared with gastroscopy, and can be used to screen gastric diseases without sedation. Clinicaltrials.gov number: NCT02219529.
胃部疾病（包括胃癌和消化性溃疡）是最常见的消化系统疾病。由于胃腔较大，目前临床上使用的被动胶囊无法对整个胃部进行可视化。我们设计了一种磁控胶囊内镜（MCE）系统来探索胃部。我们进行了一项前瞻性研究，比较了 MCE 与传统胃镜（标准方法）检测胃局灶性病变的准确性。
我们在中国的一家三级中心进行了一项多中心、盲法比较 MCE 与传统胃镜的研究，该研究纳入了 2014 年 8 月至 2014 年 12 月期间因上腹部不适拟行胃镜检查的 350 例患者（平均年龄 46.6 岁）。所有患者均先接受 MCE 检查，2 小时后不镇静行传统胃镜检查。我们以胃镜检查为标准，计算 MCE 检测胃局灶性病变的灵敏度、特异度、阳性预测值和阴性预测值。
MCE 检测整个胃的局灶性病变的灵敏度为 90.4%（95%置信区间[CI]，84.7%-96.1%）、特异度为 94.7%（95% CI，91.9%-97.5%）、阳性预测值为 87.9%（95% CI，81.7%-94.0%）、阴性预测值为 95.9%（95% CI，93.4%-98.4%），准确率为 93.4%（95% CI，90.83%-96.02%）。MCE 对上胃（贲门、胃底和胃体）局灶性病变的检出灵敏度为 90.2%（95% CI，82.0%-98.4%），特异度为 96.7%（95% CI，94.4%-98.9%）。MCE 对下胃（胃角、胃窦和幽门）局灶性病变的检出灵敏度为 90.6%（95% CI，82.7%-98.4%），特异度为 97.9%（95% CI，96.1%-99.7%）。MCE 检出 1 例进展期胃癌、2 例恶性淋巴瘤和 1 例早期胃癌。MCE 未漏诊任何有意义的病变（包括肿瘤或大溃疡）。在 350 例患者中，5 例报告了 9 例不良事件（1.4%），335 例患者更喜欢 MCE 而不是胃镜（95.7%）。
MCE 对上、下胃局灶性病变的检出与传统胃镜具有相当的准确性。与胃镜相比，MCE 几乎被所有患者所接受，可用于在不镇静的情况下筛查胃部疾病。临床试验注册号：NCT02219529。
