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

Study Overview
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Brief Summary
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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.

Official Title
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The Value of Baveno VI Criteria for Screening and Monitoring of Varices Needing Treatment in Patients With Compensated Cirrhosis

Conditions
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Cirrhosis, Varices, Non-invasive Evaluation

Intervention / Treatment
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* Diagnostic Test: Complete blood count
* Diagnostic Test: Transient elastrography
* Diagnostic Test: Endoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with liver cirrhosis diagnosed according to clinical or pathological criteria; No decompensation events in the past, no ascites shown by ultrasound, no significant abnormality in liver function and coagulation function; Willing to carry out routine diagnosis and treatment evaluation and follow-up liver stiffness test and gastroscopy; 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). Voluntarily signed the informed consent. Exclusion Criteria: Patients with liver carcinoma; Patients with portal vein thrombosis; Patients with varices requiring treatment confirmed by gastroscopy during the screening period; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Population: Patients meet Baveno VI criteria (with a liver stiffness <20kPa and with a platelet count >150,000) at baseline. | Diagnostic Test: Complete blood count<br>* Complete blood count will be conducted at 12th month and 24th month from baseline.<br>Diagnostic Test: Transient elastrography<br>* Transient elastrography, and endoscopy will be conducted at 12th month and 24th month from baseline.<br>Diagnostic Test: Endoscopy<br>* Endoscopy will be conducted at 12th month and 24th month from baseline.<br>|
| Cohort 2<br>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) | Diagnostic Test: Complete blood count<br>* Complete blood count will be conducted at 12th month and 24th month from baseline.<br>Diagnostic Test: Transient elastrography<br>* Transient elastrography, and endoscopy will be conducted at 12th month and 24th month from baseline.<br>Diagnostic Test: Endoscopy<br>* Endoscopy will be conducted at 12th month and 24th month from baseline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The missing rate of Baveno criteria at 12th month follow-up visit | The number of patients with varices requiring treatment under endoscopy divided by the number of patients meet Baveno criteria at 12th month follow-up visit | 12 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The missing rate of Baveno criteria at 24th month follow-up visit | The number of patients with varices requiring treatment under endoscopy divided by the number of patients meet Baveno criteria at 24th month follow-up visit | 24 months from baseline | 
| Cumulative rate of decompensation events | The cumulative rate of decompensated events in all participants during the 24 months. | 24 months from baseline | 
| Cumulative rate of gastrointestinal bleeding | The cumulative rate of gastrointestinal bleeding in all participants during the 24 months. | 24 months from baseline | 
| Cumulative rate of 6-week death post gastrointestinal bleeding | The cumulative rate of death in 6 weeks post gastrointestinal bleeding in patients with gastrointestinal bleeding events during the 24 months. | 24 months from baseline |