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CHESS Criteria for Varices Screening in Compensated Advanced Chronic Liver Disease (CHESS2001/APPHA2001)

Development and Validation of CHESS Criteria for the Screening of Varices in Patients With Compensated Advanced Chronic Liver Disease (CHESS2001/APPHA2001)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04307264
Enrollment
2000
Registered
2020-03-13
Start date
2020-03-18
Completion date
2023-03-17
Last updated
2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Compensated Advanced Chronic Liver Disease, Varices Needing Treatment

Keywords

Varices needing treatment, Non-invasive, Liver stiffness, Platelet count

Brief summary

Variceal hemorrhage is the serious complication in patients with compensated advanced chronic liver disease (cACLD). To evaluate the bleeding risk of varices in cACLD, esophagogastroduodenoscopy (EGD) should be performed. Once identified with medium-large varices, or small varices with red signs or Child-Pugh C class, defined as varices needing treatment (VNT), the patients with cACLD are recommended to receive the non-selective beta blockers or endoscopic variceal ligation per Baveno VI consensus. However, EGD is limited by its invasiveness and uncomfortableness. The Baveno VI criteria, which was validated by 310 patients dominant with hepatitis C virus (55.0%), recommended that EGD could be spared in patients with liver stiffness (LS) \< 20kPa and platelet count \> 150×10\^9 cells/L. Furthermore, the expanded-Baveno VI criteria (LS \< 25kPa and platelet count \> 110×10\^9 cells/L), based on European cohort with hepatitis C virus (62.8%), was able to spare more unnecessary endoscopies than the Baveno VI criteria with VNT missed rate \< 5%. Nevertheless, a recent Asian-pacific study indicated that though Baveno VI criteria was able to avoid screening endoscopy with 27.6%, it increased the odds of missing VNT in hepatitis B virus-related cACLD. Notably, this study also suggested that the expanded-Baveno VI criteria was not suited for Asian-pacific cohort with hepatitis B virus as the dominant cause with VNT missed rate \> 5%. Our study aims to develop and validate an optimal cutoff value of LS and platelet count (CHESS criteria) to safely avoid more unnecessary endoscopies in patients with hepatitis B virus-dominated cACLD.

Detailed description

Variceal hemorrhage is the serious complication in patients with compensated advanced chronic liver disease (cACLD). To evaluate the bleeding risk of varices in cACLD, esophagogastroduodenoscopy (EGD) should be performed. Once identified with medium-large varices, or small varices with red signs or Child-Pugh C class, defined as varices needing treatment (VNT), the patients with cACLD are recommended to receive the non-selective beta blockers or endoscopic variceal ligation per Baveno VI consensus. However, EGD is limited by its invasiveness and uncomfortableness. The Baveno VI criteria, which was validated by 310 patients dominant with hepatitis C virus (55.0%), recommended that EGD could be spared in patients with liver stiffness (LS) \< 20kPa and platelet count \> 150×10\^9 cells/L. Furthermore, the expanded-Baveno VI criteria (LS \< 25kPa and platelet count \> 110×10\^9 cells/L), based on European cohort with hepatitis C virus (62.8%), was able to spare more unnecessary endoscopies than the Baveno VI criteria (40.0% vs 21.5%, p \< 0.001) with VNT missed rate \< 5%. Nevertheless, a recent Asian-pacific study indicated that though Baveno VI criteria was able to avoid screening endoscopy with 27.6%, it increased the odds of missing VNT in hepatitis B virus-related cACLD. Notably, this study also suggested that the expanded-Baveno VI criteria was not suited for Asian-pacific cohort with hepatitis B virus as the dominant cause with VNT missed rate \> 5%. Our study aims to develop and validate an optimal cutoff value of LS and platelet count (CHESS criteria) to safely avoid more unnecessary endoscopies in patients with hepatitis B virus-dominated cACLD.

Interventions

PROCEDUREEsophagogasrtoduodendoscopy, liver stiffness measurement

Time frame between liver stiffness measurement and esophagogastroduodendoscopy is less than 2 weeks.

Sponsors

LanZhou University
CollaboratorOTHER
Tianjin Second People's Hospital
CollaboratorOTHER
The Sixth People's Hospital of Shenyang
CollaboratorOTHER
Ankang Central Hospital
CollaboratorOTHER
Guangxi Zhuang Autonomous Region
CollaboratorUNKNOWN
Dalian Sixth People's Hospital
CollaboratorUNKNOWN
Xingtai People's Hospital
CollaboratorOTHER
Shanghai Tongji Hospital, Tongji University School of Medicine
CollaboratorOTHER
Seventh Medical Center of PLA Army General Hospital
CollaboratorOTHER
Zhujiang Hospital
CollaboratorOTHER
The Fifth Affiliated Hospital of Zunyi Medical College
CollaboratorOTHER
Sir Run Run Shaw Hospital
CollaboratorOTHER
Beijing Tsinghua Changgeng Hospital
CollaboratorOTHER
The Central Hospital of Lishui City
CollaboratorOTHER
The Affiliated Third Hospital of Jiangsu University
CollaboratorUNKNOWN
Hepatopancreatobiliary Surgery Institute of Gansu Province
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* age 18-75 years; * confirmed cirrhosis based on liver biopsy or clinical findings; * without decompensated events (e.g. ascites, bleeding, or overt encephalopathy); * scheduled to undergo esophagogastroduodenoscopy, and liver stiffness measurement; * estimated survival time\>24 months, and model for end-stage liver disease score\<19, and without liver transplant; * with written informed consent.

Exclusion criteria

* contradictions for esophagogastroduodenoscopy; * accepted primary prevention (non-selective beta blockers or endoscopic variceal ligation); * Child-Pugh score\>9; * time frame between liver stiffness and esophagogastroduodenoscopy\>14 days; * diagnosed as hepatocellular carcinoma or other hepatobiliary and pancreatic malignancies; * splenectomy or hepatectomy; * portal vein thrombosis or cavernous transformation of portal vein; * pregnancy or unknown pregnancy status.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of CHESS criteria1 dayTo assess the accuracy of Chinese Portal Hypertension Diagnosis and Monitoring Study Group (CHESS) criteria (optimal cutoff value of liver stiffness and platelet count) to avoid unnecessary endoscopies in patients with compensated advanced chronic liver disease

Secondary

MeasureTime frameDescription
Accuracy of LSPS model1 dayTo assess the accuracy of LSPS model (liver stiffness \* spleen diameter to platelet counts) for high-risk varices in patients with compensated advanced chronic liver disease

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026