Radiomics-based Surrogate of Endoscopy (rEndosc) for Noninvasive Prediction of Esophageal Varices and Risk Stratification of Variceal Hemorrhage in Hepatitis B Virus-related Cirrhosis (CHESS1703)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 9
- 主要终点
- Diagnostic Accuracy of rEndosc for Esophageal Varices
研究概览
简要总结
Esophageal varices (EVs) resulting from portal hypertension are a prevalent complication of cirrhosis with a high mortality when variceal hemorrhage (VH) occurs. Screening endoscopy for EVs is recommended for all patients with cirrhosis, and prophylactic treatments are proposed for preventing VH, which may be financially onerous. Therefore, noninvasive tools for diagnosing EVs and risk stratifying VH in cirrhotic patients are needed to decrease the number of unnecessary invasive endoscopic examinations of low-risk patients and avoid unneeded prophylactic treatment. This is a prospective, multi-center diagnostic trial conducted at 9 high-volume liver centers in China designed to determine the diagnostic performance of radiomics-based surrogate (rEndosc) (investigational technology) by CT imaging for noninvasive prediction of EVs and risk stratification of VH in patients with hepatitis B virus-related cirrhosis using endoscopic examinations as reference standard.
详细描述
Esophageal varices (EVs) resulting from portal hypertension are a prevalent complication of cirrhosis with a high mortality when variceal hemorrhage (VH) occurs. Screening endoscopy for EVs is recommended for all patients with cirrhosis, and prophylactic treatments are proposed for preventing VH, which may be financially onerous. Therefore, noninvasive tools for diagnosing EVs and risk stratifying VH in cirrhotic patients are needed to decrease the number of unnecessary invasive endoscopic examinations of low-risk patients and avoid unneeded prophylactic treatment. This is a prospective, multi-center diagnostic trial conducted at 9 high-volume liver centers (Beijing YouAn Hospital, Capital Medical University; Nanfang Hospital, Southern Medical University; 302 Hospital of PLA; Shandong Provincial Hospital; Beijing Friendship Hospital, Capital Medical University; Chinese PLA General Hospital; Peking University People's Hospital; Xingtai People's Hospital) in China designed to determine the diagnostic performance of radiomics-based surrogate (rEndosc) (investigational technology) by CT imaging for noninvasive prediction of EVs and risk stratification of VH in patients with hepatitis B virus-related cirrhosis using endoscopic examinations as reference standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-75 years;
- •HBsAg positive;
- •confirmed cirrhosis based on results of histologic examination of liver tissue or combined physical, laboratory, and radiologic findings, including a nodular surface, a coarse texture, and an enlarged caudate lobe of the liver on ultrasonography, CT, or MR imaging.
排除标准
- •active alcohol abuse (less than 6 months of alcohol abstinence); portal thrombosis;
- •history of treatments for portal hypertension (drug therapy, such as β-blocker, vasopressin) within 2 weeks;
- •prior surgeries (such as splenectomy, partial splenic embolization/devascularization, transjugular intrahepatic portosystemic shunt);
- •prior endoscopic therapies (such as endoscopic variceal ligation);
- •previous variceal hemorrhage;
- •acute-on-chronic (sub-acute) liver failure;
- •malignant tumor (such as hepatocellular carcinoma);
- •cirrhotic portal hypertension with isolated gastric varices or ectopic varices;
- •inability to adhere to study procedures (such as heart failure, renal failure);
- •pregnancy or unknown pregnancy status;
- •no informed consent.
结局指标
主要结局
Diagnostic Accuracy of rEndosc for Esophageal Varices
时间窗: 1 day
Diagnostic accuracy of rEndosc to determine the presence or absence of esophageal varices when compared to endoscopic examination as the reference standard
次要结局
- Diagnostic Accuracy of rEndosc for Variceal Hemorrhage(1 day)
- Diagnostic Accuracy of rEndosc for the Risk of Variceal Hemorrhage(1 day)
研究者
Xiaolong Qi
Director, Portal Hypertension Research, Institute of Hepatology
Nanfang Hospital, Southern Medical University