Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Department of Gastroenterology, Zhuhai People's Hospital (Zhuhai Hospital Affiliated to Jinan University), Zhuhai, China.
Dig Endosc. 2023 Nov;35(7):857-865. doi: 10.1111/den.14548. Epub 2023 Apr 5.
The disposable esophagogastroduodenoscopy (EGD) system is a novel endoscopic device which is highly portable and is designed to eliminate the risk of cross-infection caused by reusable EGD. This study aimed to investigate the feasibility and safety of disposable EGD in emergency, bedside, and intraoperative settings.
This was a prospective, single-center, noncomparative study. Disposable EGD was used for emergency, bedside, and intraoperative endoscopies in 30 patients. The primary end-point was the technical success rate of the disposable EGD. Secondary end-points included technical performance indicators including clinical operability, image quality score, procedure time, the incidence of device malfunction and/or failure, and the incidence of adverse events.
A total of 30 patients underwent diagnosis and/or treatment with disposable EGD. Therapeutic EGD was performed on 13/30 patients, including hemostasis (n = 3), foreign body retrieval (n = 6), nasoenteric tube placement (n = 3), and percutaneous endoscopic gastrostomy (n = 1). The technical success rate was 100%: all procedures and indicated interventions were completed without changing to a conventional upper endoscope. The mean image quality score obtained immediately after procedure completion was 3.72 ± 0.56. The mean (± SD) procedure time was 7.4 (± 7.6) min. There were no device malfunctions or failures, device-related adverse events, or overall adverse events.
The disposable EGD may be a feasible alternative to the traditional EGD in emergency, bedside, and intraoperative settings. Preliminary data show that it is a safe and effective tool for diagnosis and treatment in emergency and bedside upper gastrointestinal cases.
Chinese Clinical Trial Registry (Trial ID: ChiCTR2100051452, https://www.chictr.org.cn/showprojen.aspx?proj=134284).
一次性食管胃十二指肠镜（EGD）系统是一种新型内镜设备，具有高度便携性，旨在消除可重复使用的 EGD 引起的交叉感染风险。本研究旨在探讨一次性 EGD 在急诊、床边和术中应用的可行性和安全性。
这是一项前瞻性、单中心、非对照研究。30 例患者接受了一次性 EGD 的急诊、床边和术中内镜检查。主要终点是一次性 EGD 的技术成功率。次要终点包括临床操作性、图像质量评分、操作时间、器械故障和/或失效发生率以及不良事件发生率等技术性能指标。
共 30 例患者接受了一次性 EGD 的诊断和/或治疗。13/30 例患者进行了治疗性 EGD，包括止血（n=3）、异物取出（n=6）、鼻肠管放置（n=3）和经皮内镜胃造口术（n=1）。技术成功率为 100%：所有操作和指示性干预均完成，无需更换传统上消化道内镜。操作完成后即刻获得的平均图像质量评分为 3.72±0.56。平均（±标准差）操作时间为 7.4±7.6 分钟。无器械故障或失效、器械相关不良事件或总体不良事件。
在急诊、床边和术中环境下，一次性 EGD 可能是传统 EGD 的可行替代方案。初步数据表明，它是一种安全有效的诊断和治疗工具，可用于急诊和床边上消化道病例。
中国临床试验注册中心（注册号：ChiCTR2100051452，https://www.chictr.org.cn/showprojen.aspx?proj=134284）。
