国产上消化道超声内镜有效性及安全性评估的随机、开放、平行对照、非劣性试验

Effectiveness and safety of the domestic upper gastrointestinal endoscopic ultrasound: a randomized open label non⁃inferiority controlled clinical trial

摘要:

目的 探究国产上消化道超声内镜的有效性及安全性。方法 采用分层区组随机化方法，选取2021年3月至7月中国医科大学附属盛京医院（中心1）和深圳市人民医院（中心2）的160例需要进行超声内镜诊治的患者作为研究对象，试验组使用中国开立EG⁃UC5T超声内镜，对照组使用日本富士EG⁃580UT超声内镜。有效性主要评价指标为超声图像质量优良率，比较采用非劣性验证；次要评价指标为内镜图像质量优良率、操作性能优良率和系统稳定性评价。安全性评价指标为患者术中、术后的不良事件发生情况。结果 在意向治疗分析集，试验组与对照组的超声图像质量优良率分别为100.0%（78/78）和100.0%（77/77），率差为0.0%（95%CI：-4.7%~4.8%）；在符合方案分析集，试验组与对照组的超声图像质量优良率分别为100.0%（78/78）和100.0%（75/75），率差为0.0%（95%CI：-4.7%~4.9%），两个数据集的超声图像质量优良率置信区间下限均大于非劣效界值-8%，可推断试验机非劣于对照机的非劣效假设成立。试验组与对照组的内镜图像质量优良率和操作性能优良率在意向治疗和符合方案分析中均为100.0%，差异无统计学意义（P=1.000）。系统不稳定事件发生率试验组为0.0%（0/78），对照组为3.9%（3/77），差异无统计学意义（P=0.120）。两组均无不良事件发生。结论 国产上消化道超声内镜在正常条件使用下有效性、安全性和稳定性均满足临床应用的要求。

Abstract:

Objective To investigate the effectiveness and safety of domestic upper gastrointestinal endoscopic ultrasound (EUS). Methods A total of 160 patients undergoing EUS at Shengjing Hospital of China Medical University (Center1) and Shenzhen People""s Hospital (Center 2) from March to July 2021 were randomly selected by stratified blocked randomization, and were treated with SonoScape EG-UG5T (the test group) or Fujifilm EG-580UT (the control group). The primary outcome was the ultrasound image quality excellence rate, and the comparison was verified by non-inferiority. The secondary outcomes were the endoscopic image quality excellence rate, the operational performance excellence rate, and the system stability evaluation. The safety evaluation was based on the occurrence of intraoperative and postoperative adverse events in the subjects. Results In the intention-to-treat analysis set (ITT), the excellence rate of ultrasound image quality in the test group and the control group was 100.0% (78/78) and 100.0% (77/77), respectively. The rate difference between the two groups was 0.0% (95%CI: -4.7%-4.8%). In the per protocol analysis set (PPS), the excellence rate of ultrasound image quality in the test group and the control group was 100.0% (78/78) and 100.0% (75/75), respectively. The rate difference between the two groups was 0.0% (95%CI: -4.7%-4.9%). The lower limit of the confidence interval of ultrasound image quality excellence rate of both data sets was greater than the non-inferiority threshold value of -8%, which inferred that the non-inferiority hypothesis of the test machine non-inferior to the control machine was valid. The endoscopic image quality excellence rate and the operational performance excellence rate of the test group and the control group was 100.0% in both the ITT and PPS analyses, and there was no statistically significant difference between the two groups (P=1.000). The system instability event rate was 0.0% (0/78) in the test group and 3.9% (3/77) in the control group (P=0.120). No adverse event occurred in either group. Conclusion The domestic upper gastrointestinal endoscopic ultrasound is standard-compliant for clinical application under normal conditions in terms of effectiveness, safety, and stability.