CirrhosisCHESS2204NCT05538546
Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
An observational study of Cirrhosis and Varices, run by Huashan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis, Varices, Non-invasive Evaluation
- What is being tested?
- Complete blood count, Transient elastrography and Endoscopy
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Value of Baveno VI Criteria for Screening and Monitoring of Varices Needing Treatment in Patients With Compensated Cirrhosis
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
- Being tested
- Complete blood count, Transient elastrography, Endoscopy
- Medical subject headings
- Fibrosis, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete blood countDiagnostic test
Complete blood count will be conducted at 12th month and 24th month from baseline.
Transient elastrographyDiagnostic test
Transient elastrography, and endoscopy will be conducted at 12th month and 24th month from baseline.
EndoscopyDiagnostic test
Endoscopy will be conducted at 12th month and 24th month from baseline.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Population: Patients meet Baveno VI criteria (with a liver stiffness <20kPa and with a platelet count >150,000) at baseline. Receives: 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) Receives: Diagnostic Test: Complete blood count; Diagnostic Test: Transient elastrography; Diagnostic Test: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months from baseline
Secondary outcomes (4)
The missing rate of Baveno criteria at 24th month follow-up visit
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
Measured: 24 months from baseline
Cumulative rate of decompensation events
The cumulative rate of decompensated events in all participants during the 24 months.
Measured: 24 months from baseline
Cumulative rate of gastrointestinal bleeding
The cumulative rate of gastrointestinal bleeding in all participants during the 24 months.
Measured: 24 months from baseline
Cumulative rate of 6-week death post gastrointestinal bleeding
The cumulative rate of death in 6 weeks post gastrointestinal bleeding in patients with gastrointestinal bleeding events during the 24 months.
Measured: 24 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 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, First Affiliated Hospital Xi'an Jiaotong University, Hebei Medical University Third Hospital, The First Affiliated Hospital of Anhui Medical University, Liuzhou Workers' Hospital, The First People's Hospital of Taicang, Xinjiang Hospital of Chinese Medicine, Jiangsu Taizhou People's Hospital, Shenzhen Third People's Hospital
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538546
- Sponsor's protocol ID
- OASIS-CHESS
- Acronym
- CHESS2204
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Baveno VI Criteria for Screening and Monitoring of Varices Needing Treatment in Patients With Compensated Cirrhosis
- ClinicalTrials.gov ID
- NCT05538546
- Acronym / sponsor ID
- CHESS2204 / OASIS-CHESS
- Conditions
- Cirrhosis, Varices, Non-invasive Evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- 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, First Affiliated Hospital Xi'an Jiaotong University, Hebei Medical University Third Hospital, The First Affiliated Hospital of Anhui Medical University, Liuzhou Workers' Hospital, The First People's Hospital of Taicang, Xinjiang Hospital of Chinese Medicine, Jiangsu Taizhou People's Hospital, Shenzhen Third People's Hospital
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: Complete blood count, Diagnostic Test: Transient elastrography, Diagnostic Test: EndoscopyPopulation: Patients meet Baveno VI criteria (with a liver stiffness <20kPa and with a platelet count >150,000) at baseline. |
| Cohort 2 | – | Diagnostic Test: Complete blood count, Diagnostic Test: Transient elastrography, Diagnostic Test: EndoscopyPopulation: 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complete blood countComplete blood count will be conducted at 12th month and 24th month from baseline. | Diagnostic test | Cohort 1, Cohort 2 |
| Transient elastrographyTransient elastrography, and endoscopy will be conducted at 12th month and 24th month from baseline. | Diagnostic test | Cohort 1, Cohort 2 |
| EndoscopyEndoscopy will be conducted at 12th month and 24th month from baseline. | Diagnostic test | Cohort 1, Cohort 2 |
Primary outcome
The missing rate of Baveno criteria at 12th month follow-up visit
Time frame: 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
4 secondary outcomes
The missing rate of Baveno criteria at 24th month follow-up visit
Time frame: 24 months from baseline
Cumulative rate of decompensation events
Time frame: 24 months from baseline
Cumulative rate of gastrointestinal bleeding
Time frame: 24 months from baseline
Cumulative rate of 6-week death post gastrointestinal bleeding
Time frame: 24 months from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Varices, run by Huashan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiran Zhang (+8618800245704, qrzhang12@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The missing rate of Baveno criteria at 12th month follow-up visit (time frame: 12 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.