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

NCT05538546 | Unknown DMC

• 1 other identifier: OASIS-CHESS
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cirrhosis; Varices; Non-invasive Evaluation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The missing rate of Baveno criteria at 24th month follow-up visit

  24 months from baseline

• Cumulative rate of decompensation events

  24 months from baseline

• Cumulative rate of gastrointestinal bleeding

  24 months from baseline

• Cumulative rate of 6-week death post gastrointestinal bleeding

  24 months from baseline

Study Arms (2)

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; Diagnostic Test: Transient elastrography; Diagnostic Test: Endoscopy

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; Diagnostic Test: Transient elastrography; Diagnostic Test: Endoscopy

Interventions

Complete blood count DIAGNOSTIC_TEST

Complete blood count will be conducted at 12th month and 24th month from baseline.

Cohort 1; Cohort 2

Transient elastrography DIAGNOSTIC_TEST

Transient elastrography, and endoscopy will be conducted at 12th month and 24th month from baseline.

Cohort 1; Cohort 2

Endoscopy DIAGNOSTIC_TEST

Endoscopy will be conducted at 12th month and 24th month from baseline.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Patients with liver cirrhosis diagnosed according to clinical or pathological criteria;
• No decompensation events in the past, no ascites shown by ultrasound, no significant abnormality in liver function and coagulation function;
• Willing to carry out routine diagnosis and treatment evaluation and follow-up liver stiffness test and gastroscopy;
• 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).
• Voluntarily signed the informed consent.

You may not qualify if:

• Patients with liver carcinoma;
• Patients with portal vein thrombosis;
• Patients with varices requiring treatment confirmed by gastroscopy during the screening period;
• 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.

Sponsors & Collaborators

• Huashan Hospital: lead
• Fifth Hospital of Shijiazhuang City: collaborator
• The Sixth Hospital of Qingdao: collaborator
• The Sixth Hospital of Dalian: collaborator
• The Third People's Hospital of Taiyuan: collaborator
• The Fourth People's Hospital of Qinghai Province: collaborator
• Affiliated Hospital of Nanjing University of Chinese Medicine: collaborator
• The Fifth People's Hospital of Wuxi Affiliated Hospital of Jiangnan University: collaborator
• Beilun Hospital of Chinese Medicine: collaborator
• Gansu Wuwei Tumor Hospital: collaborator
• The Affiliated Hospital of Xuzhou Medical University: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator
• The Third People's Hospital of Linfen City: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• The Third Affiliated Hospital of Hebei Medical University: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Liuzhou Workers' Hospital: collaborator
• The First People's Hospital of Taicang: collaborator
• Xinjiang Hospital of Chinese Medicine: collaborator
• Taizhou People's Hospital: collaborator
• Shenzhen Third People's Hospital: collaborator

MeSH Terms

Conditions

Fibrosis; Varicose Veins

Interventions

Blood Cell Count; Endoscopy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Qiran Zhang

CONTACT

+8618800245704; qrzhang12@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 14, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: September 14, 2022

Record last verified: 2022-09