CHESS2204: Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- The missing rate of Baveno criteria at 12th month follow-up visit [12 months from baseline]
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
Secondary Outcome Measures
- The missing rate of Baveno criteria at 24th month follow-up visit [24 months from baseline]
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
- Cumulative rate of decompensation events [24 months from baseline]
The cumulative rate of decompensated events in all participants during the 24 months.
- Cumulative rate of gastrointestinal bleeding [24 months from baseline]
The cumulative rate of gastrointestinal bleeding in all participants during the 24 months.
- Cumulative rate of 6-week death post gastrointestinal bleeding [24 months from baseline]
The cumulative rate of death in 6 weeks post gastrointestinal bleeding in patients with gastrointestinal bleeding events during the 24 months.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with liver cirrhosis diagnosed according to clinical or pathological criteria;
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No decompensation events in the past, no ascites shown by ultrasound, no significant abnormality in liver function and coagulation function;
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Willing to carry out routine diagnosis and treatment evaluation and follow-up liver stiffness test and gastroscopy;
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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).
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Voluntarily signed the informed consent.
Exclusion Criteria:
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Patients with liver carcinoma;
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Patients with portal vein thrombosis;
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Patients with varices requiring treatment confirmed by gastroscopy during the screening period;
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Huashan Hospital
- Fifth Hospital of Shijiazhuang City
- 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 Hospital of Chinese Medicine affiliated to 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 Affiliated Hospital of Xuzhou Medical University
- First Affiliated Hospital of Fujian Medical University
- The Third People's Hospital of Linfen City
- The First Affiliated Hospital of Xian Jiaotong University
- The Third Affiliated Hospital of Hebei Medical University
- The First Affiliated Hospital of Anhui Medical University
- Liuzhou Workers Hospital
- The First People's Hospital of Taicang
- Xinjiang Hospital of Chinese Medicine
- Taizhou People's Hospital
- Shenzhen Third People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OASIS-CHESS