An observational study in Varices and Liver Cirrhosis, sponsored by Beijing 302 Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-30.
Sponsored by Beijing 302 Hospital · Observational
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.
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 151 across 587 observational studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Beijing 302 Hospital is the lead sponsor of 86 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis.
Exclusion Criteria:
patients before the study started
Diagnostic Test: different diagnostic models
spatients after the study started
Diagnostic Test: different diagnostic models
the patients were screened by different diagnostic models
diagnostic performance
sensitivity, specificity, positive predictive value, negative predictive value and accuracy of different diagnostic models
Time frame: at end of the patient enrollment
Endoscopy spared ratio
the percentage of patients spared with endoscopy
Time frame: at end of the patient enrollment
HRV missing ratio
the percentage of patients missed with high-risk varices
Time frame: at end of the patient enrollment
Plan to share: No — After enrollment and data analysis, the study results will be submitted to peer-reviewed journals for publication. Personal information about potential and enrolled participants will be strictly confidential to the public before, during, and after the study.
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Beijing 302 Hospital