Effectiveness and safety of the domestic upper gastrointestinal endoscopic ultrasound: a randomized open label non-inferiority controlled clinical trial
10.3760/cma.j.cn321463-20231025-00433
- VernacularTitle: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
- Author:
Nan GE
1
;
Xin YANG
;
Kai ZHANG
;
Jinlong HU
;
Sheng WANG
;
Jintao GUO
;
Xiang LIU
;
Guoxin WANG
;
Yunliang CHEN
;
Siyu SUN
Author Information
1. 中国医科大学附属盛京医院消化内科，沈阳 110004
- Keywords:
Upper gastrointestinal tract;
Endoscopic ultrasound;
Noninferiority research
- From:
Chinese Journal of Digestive Endoscopy
2024;41(5):351-358
- CountryChina
- Language:Chinese
-
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.
