Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
NCT ID: NCT05538546
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2022-09-30
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Population: Patients meet Baveno VI criteria (with a liver stiffness \<20kPa and with a platelet count \>150,000) at baseline.
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.
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)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
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.
18 Years
70 Years
ALL
No
Sponsors
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Fifth Hospital of Shijiazhuang City
OTHER
The Sixth Hospital of Qingdao
UNKNOWN
The Sixth Hospital of Dalian
UNKNOWN
The Third People's Hospital of Taiyuan
OTHER
The Fourth People's Hospital of Qinghai Province
OTHER
Affiliated Hospital of Nanjing University of Chinese Medicine
OTHER
The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University
UNKNOWN
Beilun Hospital of Chinese Medicine
UNKNOWN
Gansu Wuwei Tumor Hospital
OTHER
The Affiliated Hospital of Xuzhou Medical University
OTHER
First Affiliated Hospital of Fujian Medical University
OTHER
The Third People's Hospital of Linfen City
UNKNOWN
The First Affiliated Hospital of Xian Jiaotong University
UNKNOWN
The Third Affiliated Hospital of Hebei Medical University
UNKNOWN
The First Affiliated Hospital of Anhui Medical University
OTHER
Liuzhou Workers' Hospital
OTHER_GOV
The First People's Hospital of Taicang
UNKNOWN
Xinjiang Hospital of Chinese Medicine
UNKNOWN
Taizhou People's Hospital
UNKNOWN
Shenzhen Third People's Hospital
OTHER
Huashan Hospital
OTHER
Responsible Party
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Wen-hong Zhang
Professor
Central Contacts
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Other Identifiers
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OASIS-CHESS
Identifier Type: -
Identifier Source: org_study_id
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