Endoscopic Ruler for the Assessment of Variceal Bleeding Risks in Portal Hypertension (CHESS2005): A Prospective Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 266
- 试验地点
- 7
- 主要终点
- The intraclass correlation coefficient (ICC) of the varix size and the kappa value of the varices bleeding risk between endoscopists and endoscopic ruler
研究概览
简要总结
The presence of varices is a serious complication of portal hypertension in liver disease. To prevent variceal haemorrhage, screening and surveillance aims to detect high-risk varices related to varices size and determine the need for primary prophylaxis. Varices size evaluated by endoscopists might not be perfect reference, influenced by experience and machine. Endoscopic ruler is a novel tool to measure the varices size under the endoscopy. The investigators aim to evaluate the bias of varices size between endoscopists and endoscopic ruler as the reference.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 75 years
- •clinically evident or biopsy-confirmed cirrhosis
- •Varices diagnosed by endoscopy
- •written informed consent
排除标准
- •Active upper gastrointestinal bleeding
结局指标
主要结局
The intraclass correlation coefficient (ICC) of the varix size and the kappa value of the varices bleeding risk between endoscopists and endoscopic ruler
时间窗: 2020/11/13-2022/11/13
次要结局
- The bleeding rate of endoscopic ruler(2020/11/13-2022/11/13)
- The timing of endoscopic ruler(2020/11/13-2022/11/13)
- The ICC value of the varix size and the kappa value of the varices bleeding risk among endoscopists(2020/11/13-2022/11/13)
- The correlation coefficient between varices size and hepatic venous pressure gradient(2020/11/13-2022/11/13)
- The correlation coefficient between varices size and decompensated events(2020/11/13-2022/11/13)
研究者
Xiaolong Qi
Director, Institute of Portal Hypertension
Hepatopancreatobiliary Surgery Institute of Gansu Province