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临床试验/NCT06392503
NCT06392503招募中不适用

Establishment of Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis Patients Based on iLivTouch

Beijing 302 Hospital1 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2023年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
1
主要终点
diagnostic performance

研究概览

简要总结

This is an observational ambispective cohort study to validate the Baveno VI guideline and develop a new diagnostic model to screen high-risk varices (HRV) of liver cirrhosis using iLivTouch.

详细描述

Esophageal variceal bleeding is a common and fatal complication in patients with liver cirrhosis. The diagnosis of high-risk varices (HRV) traditionally depends on gastroscopy, which is expensive and poorly tolerated with patients. Baveno VI guideline has put forward a HRV screening model based on liver stiffness and platelet count. This is an observational ambispective cohort study. The retrospective cohort is derived from the previous records of the hospital information system, and the prospective cohort is enrolled prospectively at the local research center when participants meet the inclusion criteria. The purpose of this study is to establish a diagnostic model of HRV in patients with liver cirrhosis according to the liver stiffness value measured by iLivTouch and other laboratory indexes, so as to verify the applicability of Baveno VI standard under the condition of iLivTouch and establish a cutoff value that is more suitable for iLivTouch. In addition, this study will try to find some new indexes to further improve the diagnostic efficiency of HRV. The minimum enrolment period is anticipated to be 6 months per center and will be extended if necessary to reach the overall study target.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

入选标准

  • Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis;
  • The interval of iLivTouch and esophagogastroduodenoscopy is no more than 3 months;

排除标准

  • the interval between esophagogastroduodenoscopy and iLivTouch is more than 3 months;
  • any decompensation events (ascites, hepatic encephalopathy or gastroesophageal variceal bleeding) during endoscopy or iLivTouch examination, or during the interval between them;
  • currently taking nonselective beta blocker/ antiplatelet / anticoagulant drugs;
  • hepatocellular carcinoma;
  • after transjugular intrahepatic portosystemic shunt surgery;
  • after liver transplantation.
  • portal-spleen-mesenteric venous thrombosis;
  • patients with splenectomy;
  • patients with acute active hepatitis or patients with cholestatic hepatitis;
  • IQR/median of liver stiffness measurement > 30%.

结局指标

主要结局

diagnostic performance

时间窗: at end of the patient enrollment

sensitivity, specificity, positive predictive value, negative predictive value and accuracy of different diagnostic models

次要结局

未报告次要终点

研究者

发起方
Beijing 302 Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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