Effect of the Automatic Surveillance System on Surveillance Rate of Patients with Gastric Premalignant Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,460
- 试验地点
- 4
- 主要终点
- On-time Surveillance Rate
研究概览
简要总结
In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups will be compared.
详细描述
The adherence of doctors to published surveillance guidelines for patients with gastric premalignant lesions varies greatly, and surveillance of patients is critical but time-consuming. In previous studies we developed an automatic surveillance (AS) system to accurately identify patients with gastric premalignant lesions, assign surveillance intervals for different risks of patients and proactively follow up with patients in time. In this study, we proposed a prospective study about the effect of the automatic surveillance system on surveillance rate of patients with gastric premalignant lesions. The enrolled patients were divided into group A with intelligent surveillance system, group B with manual reminder, and group C with natural state. The surveillance among the three groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or older who undergo upper endoscopy.
排除标准
- •No contact information or invalid contact information.
- •The surveillance interval cannot be determined according to the surveillance guidelines, including no upper gastrointestinal pathology, therapeutic endoscopy or with history of previous gastrectomy, esophagectomy, or ESD, no dysplasia degrees, no biopsy sites, non-epithelial lesions, duodenal lesions, ulcer and so on.
- •Needless for surveillance or others.
- •High-grade intraepithelial neoplasia or cancer of the esophagus or stomach.
- •Low-grade intraepithelial neoplasia of the esophagus and Barrett's esophagus.
- •High-risk diseases or other special conditions for which the patient is deemed unsuitable for clinical trials by the investigator.
研究组 & 干预措施
With automatic surveillance system
Patients were reminded of the surveillance time by an automatic surveillance system after the endoscopic and pathological results were available and before the surveillance time.
干预措施: AI based automatic surveillance (AS) system (ENDOANGEL-AS) (Other)
With manual reminder
Patients were reminded of the surveillance time manually after the endoscopic and pathological results were available and before the surveillance time.
干预措施: Manually remind the patients (Other)
Normal group
The patients in the control group were observed in the clinical natural state of surveillance without automatic surveillance system or manual reminder.
结局指标
主要结局
On-time Surveillance Rate
时间窗: From enrollment to study completion, assessed up to 3 years.
The numerator is the number of patients with on-time surveillance, and the denominator is the number of all patients with gastric premalignant lesions requiring surveillance.
次要结局
- lesion regression rate(From enrollment to study completion, assessed up to 3 years.)
- Surveillance Rate(From enrollment to study completion, assessed up to 3 years.)
- The accuracy of classifying risk levels(1 day At the time of enrollment)
- The incidence rate of early gastric cancer(From enrollment to study completion, assessed up to 3 years.)
- The incidence rate of gastric cancer(From enrollment to study completion, assessed up to 3 years.)
- The accuracy of identifying patients with gastric premalignant lesions(1 day At the time of enrollment)
- The accuracy of assigning surveillance intervals(1 day At the time of enrollment)
- Delayed Surveillance Rate(From enrollment to study completion, assessed up to 3 years.)
- lesion persistence rate(From enrollment to study completion, assessed up to 3 years.)
- Advance Surveillance Rate(From enrollment to study completion, assessed up to 3 years.)
- lesion progression rate(From enrollment to study completion, assessed up to 3 years.)