An observational study in Compensated Advanced Chronic Liver Disease and Varices Needing Treatment, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Completed at 15 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-25.
Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Observational
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.
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 2,000 is above the median of 167 across 681 observational studies indexed under Liver Diseases.
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Patient with compensated advanced chronic liver disease
Exclusion Criteria:
Eligible participants will receive standard esophagogasrtoduodendoscopy, liver stiffness measurement and serological examination (platelet count, alanine aminotransferase, aspartate aminotransferase, total bilirubin, Prothrombin time, albumin).
Procedure: Esophagogasrtoduodendoscopy, liver stiffness measurement
Time frame between liver stiffness measurement and esophagogastroduodendoscopy is less than 2 weeks.
Accuracy of CHESS criteria
To 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
Time frame: 1 day
Accuracy of LSPS model
To 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
Time frame: 1 day
Plan to share: Undecided
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Hepatopancreatobiliary Surgery Institute of Gansu Province