新型便携式内镜系统应用于上消化道疾病检查的多中心临床研究

A novel portable endoscopy system for upper gastrointestinal examination:a multicenter clinical study

目的评估新型便携式内镜系统在上消化道内镜检查中的操作性能、有效性和安全性。方法采用多中心、开放性、随机、非劣效性对照研究, 2019年6月-2020年6月间由3个临床研究中心参与, 纳入消化内科门诊就诊的90例患者作为研究对象, 随机分配到试验组和对照组, 试验组接受便携式内镜完成上消化道检查(n=44), 对照组接受临床常规应用的奥林巴斯胃镜完成上消化道检查(n=46)。以后者作为参照, 对新型便携式内镜系统的检查成功率、图像质量、操作性能、操作总体满意度、活检成功率和安全性进行评价。结果试验组内镜检查成功率为97.73%(43/44), 对照组为100.00%(46/46), 差值为-2.27%(95%CI:-6.68%~2.13%), 大于设定的非劣效界值(-10%);试验组与对照组图像质量综合评价优良率均为100%, 差值为0, 大于设定的非劣效界值(-10%)。对照组操作系统性能优良率为100.00%(46/46), 试验组为97.67%(42/43), 2组间差异无统计学意义(P=0.483);对照组操作总体满意率为100.00%(46/46), 试验组为86.05%(37/43), 2组间差异有统计学意义(P=0.011);共9例进行了内镜下活检, 试验组5例、对照组4例, 2组活检通道均顺畅, 均能顺利完成活检。共16例出现不良事件, 对照组5例[10.87%(5/46)], 试验组11例[25.00%(11/44)], 2组间不良事件发生率比较差异无统计学意义(χ^(2)=3.07, P=0.080), 所有不良事件均在48 h内消失, 无严重不良事件及器械缺陷事件发生。结论新型便携式内镜系统安全性高, 操作性能与图像质量良好, 与临床常用的日本奥林巴斯内镜系统效果相当, 可推广应用。

Objective To evaluate the performance,efficacy and safety of a novel portable endoscopy system for upper gastrointestinal examination.Methods A multicentered,open-label,randomized,non-inferiority controlled study was conducted in 3 clinical research centers from June 2019 to June 2020,and a total of 90 outpatients admitted to Department of Gastroenterology were randomly assigned to the trial group(n=44)undergoing portable endoscopy and the control group(n=A6)undergoing Olympus endoscopy.The examination success rate,image quality,performance,overall operation satisfaction rate,biopsy success rate and adverse events of the two groups were compared.Results The examination success rates of the trial group and the control group were 97.73%(43/44)and 100.00%(46/46)respectively with a difference of-2.27%(95%CI:-6.68%-2.13%),higher than the set non-inferiority margin of-10%.Rates of good and excellent image quality were 100%in both groups,and the difference of 0 was higher than the set non-inferiority margin of-10%.There was no significant difference in the rate of good and excellent performance of the operating system between the two groups[97.67%(42/43)VS 100.00%(46/46),P=0.483].There was significant difference in the overall satisfactory rate of the operation between the two groups[86.05%(37/43)VS 100.00%(46/46),P=0.011].A total of 9 cases underwent endoscopic biopsy,including 5 cases in the trial group and 4 cases in the control group.The biopsy channels in both groups were smooth and the biopsy were successfully completed.There was no significant difference in adverse event rate between the two groups[25.00%(11/44)VS 10.87%(5/46),χ^(2)=3.07,P=0.080].All adverse events disappeared in 48 hours,and no severe adverse events or device defect events occurred.Conclusion The novel portable endoscopic system is comparable to Olympus endoscopic system in terms of the operating performance,the image quality and safety.Therefore,this system is safe and effective for upper gastrointestinal examination.