Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis

Recruiting

• Conditions: Liver Cirrhosis; Varices
• Interventions: Diagnostic Test: different diagnostic models

• Registration Number: NCT06392503
• Lead Sponsor: Beijing 302 Hospital

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.

Detailed 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 Timeline

• Study Start: 2023-11-30
• Status Verified: 2024-03
• Study First Submitted: 2024-04-26
• Study First Submitted QC: 2024-04-26
• Last Update Submitted: 2024-04-26
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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%.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
retrospective cohort group	different diagnostic models	patients before the study started
prospective cohort group	different diagnostic models	spatients after the study started

Primary Outcome Measures

Name	Time	Method
diagnostic performance	at end of the patient enrollment	sensitivity, specificity, positive predictive value, negative predictive value and accuracy of different diagnostic models

Trial Locations

Locations (1)

the Fifth Medical Center, Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China