Cirrhosis, Non-invasive Evaluation, Varices
Conditions
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.
Interventions
DIAGNOSTIC_TESTComplete blood count
Complete blood count will be conducted at 12th month and 24th month from baseline.
DIAGNOSTIC_TESTTransient elastrography
Transient elastrography, and endoscopy will be conducted at 12th month and 24th month from baseline.
DIAGNOSTIC_TESTEndoscopy
Endoscopy will be conducted at 12th month and 24th month from baseline.
Sponsors
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
Affiliated Hospital of 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
Huashan Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactQiran Zhang
Outcome results
None listed