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Recruiting NCT06392503

Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis

Trial Parameters

Condition Varices
Sponsor Beijing 302 Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 2,500
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-11-30
Completion 2025-06-30
Interventions
different diagnostic models

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Age 18-75; 2. Patients with liver cirrhosis diagnosed by clinical or imaging diagnosis; 3. The interval of iLivTouch and esophagogastroduodenoscopy is no more than 3 months; Exclusion Criteria: 1. the interval between esophagogastroduodenoscopy and iLivTouch is more than 3 months; 2. any decompensation events (ascites, hepatic encephalopathy or gastroesophageal variceal bleeding) during endoscopy or iLivTouch examination, or during the interval between them; 3. currently taking nonselective beta blocker/ antiplatelet / anticoagulant drugs; 4. hepatocellular carcinoma; 5. after transjugular intrahepatic portosystemic shunt surgery; 6. after liver transplantation. 7. portal-spleen-mesenteric venous thrombosis; 8. patients with splenectomy; 9. BMI ≥ 30; 10. patients with acute active hepatitis or patients with cholestatic hepatitis; 11. IQR/median of liver stiffness measurement \> 30%.

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