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

Beijing 302 Hospital

Status: Enrolling

Conditions: Liver Cirrhosis; Varices

Treatments: Diagnostic Test: different diagnostic models

Study type: Observational

Funder types: Other

Identifiers

NCT06392503

KY-2023-10-59-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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%.

Trial design

2,500 participants in 2 patient groups

retrospective cohort group

Description:

patients before the study started

Treatment:

Diagnostic Test: different diagnostic models

prospective cohort group

Description:

spatients after the study started

Treatment:

Diagnostic Test: different diagnostic models