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

Cirrhosis Clinical Trial

— CHESS2204  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05538546
• Other study ID #: OASIS-CHESS
• Status: Not yet recruiting
• Start date: September 2022
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: Huashan Hospital
• Contact: Qiran Zhang
• Phone: +8618800245704
• Email: qrzhang12[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Varices
• Varicose Veins

Intervention

Diagnostic Test:
• Complete blood count
Complete blood count will be conducted at 12th month and 24th month from baseline.
• Transient elastrography
Transient elastrography, and endoscopy will be conducted at 12th month and 24th month from baseline.
• Endoscopy
Endoscopy will be conducted at 12th month and 24th month from baseline.

Locations

Country	Name	City	State
n/a

Sponsors (21)

Lead Sponsor

Collaborator

Huashan Hospital

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Cumulative rate of decompensation events	The cumulative rate of decompensated events in all participants during the 24 months.	24 months from baseline
Secondary	Cumulative rate of gastrointestinal bleeding	The cumulative rate of gastrointestinal bleeding in all participants during the 24 months.	24 months from baseline
Secondary	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