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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cirrhosis; Varices; Non-invasive Evaluation
• Intervention / Treatment: Diagnostic test: Complete blood count; Diagnostic test: Transient elastrography; Diagnostic test: Endoscopy

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Qiran Zhang; Phone Number: +8618800245704; Email: qrzhang12@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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. The study population will be patients with compensated cirrhosis, and either meet Baveno VI criteria at baseline, ordon't meet Baveno VI criteria but don't have varices requiring treatment (proved by endoscopy).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; 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; Complete blood count will be conducted at 12th month and 24th month from baseline.; Diagnostic test: Transient elastrography; Transient elastrography, and endoscopy will be conducted at 12th month and 24th month from baseline.; Diagnostic test: Endoscopy; Endoscopy will be conducted at 12th month and 24th month from baseline.
Cohort 2; 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; Complete blood count will be conducted at 12th month and 24th month from baseline.; Diagnostic test: Transient elastrography; Transient elastrography, and endoscopy will be conducted at 12th month and 24th month from baseline.; Diagnostic test: Endoscopy; Endoscopy will be conducted at 12th month and 24th month from baseline.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Collaborators: Liuzhou Workers Hospital; The First Affiliated Hospital of Anhui Medical University; First Affiliated Hospital of Fujian Medical University; The Affiliated Hospital of Xuzhou Medical University; Shenzhen Third People's Hospital; Fifth Hospital of Shijiazhuang City; The First People's Hospital of Taicang; The Sixth Hospital of Qingdao; The Sixth Hospital of Dalian; The Third People's Hospital of Taiyuan; The Fourth People's Hospital of Qinghai Province; Nanjing University of Chinese Medicine; The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University; Beilun Hospital of Chinese Medicine; Gansu Wuwei Tumor Hospital; The Third People's Hospital of Linfen City; The First Affiliated Hospital of Xian Jiaotong University; The Third Affiliated Hospital of Hebei Medical University; Xinjiang Hospital of Chinese Medicine; Taizhou People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 10, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 10, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Fibrosis; Liver Cirrhosis; Varicose Veins
• Other Study ID Numbers: OASIS-CHESS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No