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Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis — NID-HRV  

Liver Cirrhosis Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06392503
Study type Observational
Source Beijing 302 Hospital
Contact Fu junliang, PHD
Phone 010-66933214
Email fjunliang@163.com
Status Recruiting
Phase
Start date November 30, 2023
Completion date December 31, 2025
View Details
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