Department of Gastroenterology, The Second Affiliated Hospital, The Third Military Medical University, Chongqing, China.
Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Lancet Gastroenterol Hepatol. 2021 Nov;6(11):914-921. doi: 10.1016/S2468-1253(21)00274-0. Epub 2021 Sep 21.
The use of magnetically controlled capsules for gastroscopy is in the early stages of clinical adoption. We aimed to evaluate the safety and efficacy of a fully automated magnetically controlled capsule endoscopy (FAMCE) system in clinical practice for gastroscopy and small bowel examination.
We did a prospective, comparative study to evaluate the safety and efficacy of FAMCE. Patients from two hospitals in Chongqing, China were consecutively enrolled. Eligible participants were aged 18-80 years with suspected gastric pathology and no previous surgery. Participants underwent FAMCE for screening of gastric lesions, then conventional transoral gastroscopy 2 h later, and stomach examination results were compared. The primary outcome was the rate of complete detection of gastric anatomy landmarks (cardia, fundus, body, angulus, antrum, and pylorus) by FAMCE. Secondary outcomes were the time required for gastric completion by FAMCE, the rate of detection of gastric lesions by FAMCE compared with conventional transoral gastroscopy, and the rate of complete small bowel examination. Adverse events were also evaluated. The study was registered in the Chinese Clinical Trial Registry, ChiCTR2000040507.
Between May 12 and Aug 17, 2020, 114 patients (mean age 44·0 years [IQR 34·0-55·0]; 63 [55%] female) were enrolled. The rate of complete detection of gastric anatomical structures by FAMCE was 100% (95% CI 99·3-100·0). The concordance between FAMCE and conventional transoral gastroscopy was 99·61% (99·45-99·78). The mean completion time of a gastroscopy with FAMCE was 19·17 min (SD 1·43; median 19·00, IQR 19·00-20·00), compared with 5·21 min (2·00; 5·18, 3·68-6·45) for conventional transoral gastroscopy. In 114 enrolled patients, 214 lesions were detected by FAMCE and conventional transoral gastroscopy. Of those, 193 were detected by both modalities. FAMCE missed five pathologies (four cases of gastritis and one polyp), whereas conventional transoral gastroscopy missed 16 pathologies (12 cases of gastritis, one polyp, one fundal xanthoma, and two antral erosions). FAMCE was able to provide a complete small bowel examination for all 114 patients and detected intestinal lesions in 50 (44%) patients. During the study, two (2%) patients experienced adverse events. No serious adverse events were recorded, and there was no evidence of capsule retention.
The performance of FAMCE is similar to conventional transoral gastroscopy in completion of gastric examination and lesion detection. Furthermore, it can provide a complete small bowel examination. Therefore, FAMCE could be effective method for examination of the gastrointestinal tract.
Chinese National Key Research and Development Program.
磁控胶囊内镜用于胃镜检查仍处于临床应用的早期阶段。本研究旨在评估一种全自动磁控胶囊内镜（FAMCE）系统在胃镜和小肠检查中的临床应用的安全性和有效性。
我们进行了一项前瞻性、对照研究，以评估 FAMCE 的安全性和有效性。来自中国重庆市的两家医院的患者连续入组。纳入标准为年龄 18-80 岁，疑似胃病变，且无既往手术史。参与者首先接受 FAMCE 筛查胃病变，然后在 2 小时后行常规经口胃镜检查，并比较胃检查结果。主要结局是 FAMCE 完全检测到胃解剖标志（贲门、胃底、胃体、胃角、胃窦和幽门）的比例。次要结局是 FAMCE 完成胃检查所需的时间、FAMCE 检测到的胃病变与常规经口胃镜的比例，以及完全小肠检查的比例。还评估了不良事件。该研究在中国临床试验注册中心注册，注册号 ChiCTR2000040507。
2020 年 5 月 12 日至 8 月 17 日，共纳入 114 名患者（平均年龄 44.0 岁[IQR 34.0-55.0]；63 名[55%]为女性）。FAMCE 完全检测到胃解剖结构的比例为 100%（95%CI 99.3-100.0）。FAMCE 与常规经口胃镜的一致性为 99.61%（99.45-99.78）。FAMCE 完成胃镜检查的平均时间为 19.17 分钟（SD 1.43；中位数 19.00，IQR 19.00-20.00），而常规经口胃镜检查的平均时间为 5.21 分钟（2.00；5.18，3.68-6.45）。在 114 名入组患者中，FAMCE 和常规经口胃镜共检出 214 处病变。其中，两种方法均检出 193 处病变。FAMCE 漏诊 5 处病变（4 例胃炎和 1 例息肉），而常规经口胃镜漏诊 16 处病变（12 例胃炎、1 例息肉、1 例胃底黄斑瘤和 2 例胃窦糜烂）。FAMCE 能够对所有 114 名患者进行完整的小肠检查，并在 50 名（44%）患者中检测到肠道病变。研究期间，有 2 名（2%）患者发生不良事件。无严重不良事件发生，且无胶囊滞留证据。
FAMCE 在完成胃检查和检测病变方面的性能与常规经口胃镜相似。此外，它还可以提供完整的小肠检查。因此，FAMCE 可能是一种有效的胃肠道检查方法。
中国国家重点研发计划。
