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临床试验/NCT05293457
NCT05293457Unknown不适用

A Prospective Multicenter Study of AI-assisted Gastroscopic Varices Diagnosis

Renmin Hospital of Wuhan University1 个研究点 分布在 1 个国家目标入组 793 人开始时间: 2022年4月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
793
试验地点
1
主要终点
The accuracy of artificial intelligence

研究概览

简要总结

Validation of the accuracy of AI in assisting gastroscopic varices diagnosis through a prospective multicenter study

详细描述

This study is a multi-center prospective study. Patients who meet the inclusion and exclusion criteria of the study will collect their basic information during outpatient and hospitalization. The designated doctor will introduce the significance of this study to the patients and sign the informed consent. After the endoscopy of the patient, the video of the operation under the endoscope was collected and saved, and the AI was imported to obtain its conclusions on the above characteristics, as well as stratification and treatment recommendations. Follow-up requirements for third-party physicians who meet the inclusion criteria, record their various diagnosis and treatment recommendations after watching the video (mainly in the form of a selection questionnaire to avoid subjective bias), and the content of the questionnaire includes the veins observed in the endoscopic operation video. Varicose related features (with or without red sign, bleeding sign, varicose vein shape, diameter, color, mucosal sign), and corresponding risk stratification and treatment recommendations are required. For videos with inconsistent conclusions between AI and physicians, physicians will be asked to watch these videos with AI prompts again to give their opinions, and there will be a two-week buffer period between the first time and the second viewing. The reference standard for diagnosis will be obtained by three endoscopists watching videos without AI prompts, and the conclusions drawn by the three experts will be used as the reference standard. When the three experts have inconsistent conclusions, the three experts will discuss A consensus shall prevail. If no consensus can be reached in the end, the video will be discarded.

Primary and secondary endpoints were obtained by comparing the accuracy of diagnosis made by physicians and AI. All data were analyzed by SPSS statistical software.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged 18 years or above;
  • Gastroscopy and related examinations are required to further clarify the characteristics of digestive tract diseases;
  • Patients with liver cirrhosis who have signs or symptoms of portal hypertension and have clinical indications for endoscopic screening for varicose veins.
  • Able to read, understand and sign the informed consent;
  • The researcher believes that the subjects can understand the process of the clinical study, are willing and able to complete all the research procedures and follow-up visits, and cooperate with the research procedures.

排除标准

  • Pregnant or breastfeeding women; 2) Patients with a history of esophagogastric surgery; 3) Patients who have received interventional or endoscopic treatment in the past; 4) The patient has high-risk diseases or other special conditions that are not suitable for participating in clinical trials; 5) The patient is clearly diagnosed with esophageal or gastric diverticulum, polyps, cancer and other diseases that may affect the observation of varicose veins; 6) The patient's endoscopic video cannot reach a consensus diagnosis and treatment opinion after being watched by three experts.

结局指标

主要结局

The accuracy of artificial intelligence

时间窗: 2022/12/25

Accuracy of AI in the description and treatment recommendations of esophagogastric varices diagnosis and endoscopic findings (form, color, red sign, hemorrhagic sign, and mucosal findings).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ChenMingkai

Clinical Professor

Renmin Hospital of Wuhan University

研究点 (1)

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