Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients (CHESS2204)

Fudan University

Status: Not yet enrolling

Conditions: Cirrhosis; Non-invasive Evaluation; Varices

Treatments: Diagnostic Test: Transient elastrography; Diagnostic Test: Endoscopy; Diagnostic Test: Complete blood count

Study type: Observational

Funder types: Other

Identifiers

NCT05538546

OASIS-CHESS

Details and patient eligibility

About

Patients meet Baveno VI criteria (with a liver stiffness <20kPa and with a platelet count >150,000 are considered to have very low risk of having varices requiring treatment, but whether these patients can be followed up by repetition of this criteria lacks sufficient evidence. This study aimed to assess the value of Baveno VI criteria for following up and monitoring of varices needing treatment in patients with compensated cirrhosis.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with liver cirrhosis diagnosed according to clinical or pathological criteria;
2. No decompensation events in the past, no ascites shown by ultrasound, no significant abnormality in liver function and coagulation function;
3. Willing to carry out routine diagnosis and treatment evaluation and follow-up liver stiffness test and gastroscopy;
4. Patients meet Baveno VI criteria (with a liver stiffness <20kPa and with a platelet count >150,000) at baseline, or patients don't meet Baveno VI criteria (with a liver stiffness ≥ 20kPa or with a platelet count ≤150,000) at baseline, but don't have varices requiring treatment (proved by endoscopy).
5. Voluntarily signed the informed consent.

Exclusion criteria

1. Patients with liver carcinoma;
2. Patients with portal vein thrombosis;
3. Patients with varices requiring treatment confirmed by gastroscopy during the screening period;
4. Patients who have received propranolol, ligation, sclerosis, splenectomy, transcatheter splenic arterial embolization, transjugular interhepatic portosystemicstent-shunt and other treatments to decrease portal hypertension in the past.

Trial design

1,000 participants in 2 patient groups

Cohort 1

Description:

Population: Patients meet Baveno VI criteria (with a liver stiffness \<20kPa and with a platelet count \>150,000) at baseline.

Treatment:

Diagnostic Test: Transient elastrography

Diagnostic Test: Complete blood count

Diagnostic Test: Endoscopy

Cohort 2

Description:

Population: Patients don't meet Baveno VI criteria (with a liver stiffness ≥ 20kPa or with a platelet count ≤150,000) at baseline, but don't have varices requiring treatment (proved by endoscopy at baseline)

Treatment:

Diagnostic Test: Transient elastrography

Diagnostic Test: Complete blood count

Diagnostic Test: Endoscopy