Clinical trial NCT05538546: Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Official title: The Value of Baveno VI Criteria for Screening and Monitoring of Varices Needing Treatment in Patients With Compensated Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cirrhosis
Varices
Non-invasive Evaluation
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Fifth Hospital of Shijiazhuang City
name: The Sixth Hospital of Qingdao
name: The Sixth Hospital of Dalian
name: The Third People's Hospital of Taiyuan
name: The Fourth People's Hospital of Qinghai Province
name: Affiliated Hospital of Nanjing University of Chinese Medicine
name: The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University
name: Beilun Hospital of Chinese Medicine
name: Gansu Wuwei Tumor Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: First Affiliated Hospital of Fujian Medical University
name: The Third People's Hospital of Linfen City
name: The First Affiliated Hospital of Xian Jiaotong University
name: The Third Affiliated Hospital of Hebei Medical University
name: The First Affiliated Hospital of Anhui Medical University
name: Liuzhou Workers Hospital
name: The First People's Hospital of Taicang
name: Xinjiang Hospital of Chinese Medicine
name: Taizhou People's Hospital
name: Shenzhen Third People's Hospital
First posted: 2022-09-14
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The missing rate of Baveno criteria at 12th month follow-up visit
timeFrame: 12 months from baseline
Secondary outcomes:
measure: The missing rate of Baveno criteria at 24th month follow-up visit
timeFrame: 24 months from baseline
measure: Cumulative rate of decompensation events
timeFrame: 24 months from baseline
measure: Cumulative rate of gastrointestinal bleeding
timeFrame: 24 months from baseline
measure: Cumulative rate of 6-week death post gastrointestinal bleeding
timeFrame: 24 months from baseline
Other outcomes:
Locations:
Study officials:
References: