Noninvasive Diagnosis Model for High-risk Varices in Cirrhosis

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06392503

Acronym

NID-HRV

Enrollment

2500

Registered

2024-04-30

Start date

2023-11-30

Completion date

2025-12-31

Last updated

2024-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Varices

Keywords

diagnostic model, high risk varices, iLivTouch

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.

Interventions

DIAGNOSTIC_TESTdifferent diagnostic models

the patients were screened by different diagnostic models

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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%.

Design outcomes

Primary

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

Other

Measure	Time frame	Description
Endoscopy spared ratio	at end of the patient enrollment	the percentage of patients spared with endoscopy
HRV missing ratio	at end of the patient enrollment	the percentage of patients missed with high-risk varices

Countries

China

Contacts

Primary ContactFu junliang, PHD

fjunliang@163.com010-66933214

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026