Zhu Jia-Hui, Pan Jun, Xu Xiao-Nan, Liu Ya-Wei, Qian Yang-Yang, Jiang Xi, Jiang Bin, Zhou Wei, Linghu En-Qiang, Li Zhao-Shen, Liao Zhuan
National Clinical Research Center for Digestive Diseases, Department of Gastroenterology, Changhai Hospital, Shanghai, China.
Department of Gastroenterology, The First Medical Center of PLA General Hospital/Chinese PLA Postgraduate Military Medical School, Beijing, China.
Endosc Int Open. 2022 Feb 15;10(2):E163-E170. doi: 10.1055/a-1648-2238. eCollection 2022 Feb.
Endoscopists have been at increased risk because of their direct contact with patients during the COVID-19 pandemic. For patients, being diagnosed with and monitored for gastrointestinal cancer and digestive diseases in timely fashion has been challenging, given pandemic-related adjustments in endoscopy departments. We developed a novel noncontact magnetically controlled capsule endoscopy (ncMCE) system in our medical center. In the current study, we aimed to evaluate the feasibility and safety of ncMCE for gastric examination. Patients were randomly assigned to groups that received ncMCE or MCE in a 1:1 ratio from March 26, 2020 to April 26, 2020. Primary endpoints were feasibility assessed by completion rate (CR) and safety based on the occurrence of adverse events (AEs) including infection. Secondary endpoints included maneuverability of endoscopists, pre-procedure perception and post-procedure satisfaction of patients, gastric examination time (GET), and diagnostic yield (DY). Forty patients were enrolled with 100 % CR in both groups without any AEs. Neither the endoscopist nor the patients were infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 14 days after gastric examination. There were no significant differences in maneuverability (19.3 vs. 20.0, = 0.179), pre-procedure perception (9 vs. 9, = 0.626) and post-procedure satisfaction (45 vs. 44, 0.999), ord DY (20 % vs. 30 %, = 0.465). ncMCE is a feasible and safe method of gastric examination, which has the potential to protect both medical staff and patients from COVID-19 infection while providing serving as an essential endoscopy service.
在新冠疫情期间，内镜医师面临的风险有所增加，因为他们需要直接接触患者。对于患者而言，在内镜科室因疫情做出调整的情况下，及时诊断和监测胃肠道癌症及消化系统疾病颇具挑战。我们医疗中心研发了一种新型非接触式磁控胶囊内镜（ncMCE）系统。在本研究中，我们旨在评估ncMCE用于胃部检查的可行性和安全性。从2020年3月26日至2020年4月26日，患者按1:1的比例被随机分配至接受ncMCE或MCE的组中。主要终点是通过完成率（CR）评估的可行性以及基于包括感染在内的不良事件（AE）发生情况的安全性。次要终点包括内镜医师的可操作性、患者术前感受和术后满意度、胃部检查时间（GET）以及诊断率（DY）。40名患者入组，两组的CR均为100%，且未发生任何AE。胃部检查后14天内，内镜医师和患者均未感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）。在可操作性（19.3对20.0，P = 0.179）、术前感受（9对9，P = 0.626）、术后满意度（45对44，P = 0.999）或DY（20%对30%，P = 0.465）方面，两组之间均无显著差异。ncMCE是一种可行且安全的胃部检查方法，它在提供基本内镜检查服务的同时，有可能保护医护人员和患者免受新冠病毒感染。
