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| Name | Class |
|---|---|
| LanZhou University | OTHER |
| Tianjin Second People's Hospital | OTHER |
| Shenyang Sixth People's Hospital | OTHER |
| Ankang Central Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Overall eligible participants | Eligible participants will receive standard esophagogasrtoduodendoscopy, liver stiffness measurement and serological examination (platelet count, alanine aminotransferase, aspartate aminotransferase, total bilirubin, Prothrombin time, albumin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagogasrtoduodendoscopy, liver stiffness measurement | Procedure | Time frame between liver stiffness measurement and esophagogastroduodendoscopy is less than 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with compensated advanced chronic liver disease
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| Name | Affiliation | Role |
|---|---|---|
| Jiahong Dong, M.D. | Beijing Tsinghua Changgeng Hospital | Study Chair |
| Xiaolong Qi, M.D. | LanZhou University | Study Chair |
| Liting Zhang, M.D. | LanZhou University | Principal Investigator |
| Lin Zhang, M.D. | Beijing Tsinghua Changgeng Hospital | Principal Investigator |
| Fengmei Wang, M.D. | Tianjin Second People's Hospital | Principal Investigator |
| Ye Gu, M.D. | Shenyang Sixth People's Hospital | Principal Investigator |
| Zicheng Jiang, M.D. | Ankang Central Hospital | Principal Investigator |
| Guo Zhang, M.D. | Guangxi Zhuang Autonomous Region | Principal Investigator |
| Yong Zhang, M.D. | Dalian Sixth People's Hospital | Principal Investigator |
| Dengxiang Liu, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankang Central Hospital | Ankang | China | ||||
| Beijing Tsinghua Changgung Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30215362 | Background | Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2. | |
| 25164003 | Background | Wang FS, Fan JG, Zhang Z, Gao B, Wang HY. The global burden of liver disease: the major impact of China. Hepatology. 2014 Dec;60(6):2099-108. doi: 10.1002/hep.27406. Epub 2014 Oct 29. |
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| OTHER |
| Guangxi Zhuang Autonomous Region | UNKNOWN |
| Dalian Sixth People's Hospital | UNKNOWN |
| Xingtai People's Hospital | OTHER |
| Shanghai Tongji Hospital, Tongji University School of Medicine | OTHER |
| Seventh Medical Center of PLA Army General Hospital | OTHER |
| Zhujiang Hospital | OTHER |
| The Fifth Affiliated Hospital of Zunyi Medical College | OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Beijing Tsinghua Changgeng Hospital | OTHER |
| The Central Hospital of Lishui City | OTHER |
| Affiliated Hospital of Jiangsu University | OTHER |
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| Xingtai People's Hospital |
| Principal Investigator |
| Li Yang, M.D. | Shanghai Tongji Hospital, Tongji University School of Medicine | Principal Investigator |
| Shuai Wang, M.D. | Seventh Medical Center of PLA Army General Hospital | Principal Investigator |
| Hua Mao, M.D. | Zhujiang Hospital | Principal Investigator |
| Chaohui He, M.D. | The Fifth Affiliated Hospital of Zunyi Medical College | Principal Investigator |
| Weiling Hu, M.D. | Sir Run Run Shaw Hospital | Principal Investigator |
| Shengqiang Zou, M.D. | Affiliated Hospital of Jiangsu University | Principal Investigator |
| Chuxiao Shao, M.D. | The Central Hospital of Lishui City | Principal Investigator |
| Beijing |
| China |
| the Seventh Medical Center of PLA General Hospital | Beijing | China |
| Dalian Sixth People's Hospital | Dalian | China |
| Zhujiang Hospital | Guangzhou | China |
| The First Hospital of Lanzhou University | Lanzhou | China |
| The Central Hospital of Lishui City | Lishui | China |
| Guangxi Zhuang Autonomous Region | Nanning | China |
| Shanghai Tongji Hospital | Shanghai | China |
| Sixth People's Hospital of Shenyang | Shenyang | China |
| Tianjin Second People's Hospital | Tianjin | China |
| Xingtai People's Hospital | Xingtai | China |
| Sir Run Run Shaw Hospital | Zhejiang | China |
| The Affiliated Third Hospital of Jiangsu University | Zhenjiang | China |
| the Fifth Affiliated Hospital of Zunyi Medical University | Zhuhai | China |
| 26047908 | Background | de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available. |
| 27388923 | Background | Maurice JB, Brodkin E, Arnold F, Navaratnam A, Paine H, Khawar S, Dhar A, Patch D, O'Beirne J, Mookerjee R, Pinzani M, Tsochatzis E, Westbrook RH. Validation of the Baveno VI criteria to identify low risk cirrhotic patients not requiring endoscopic surveillance for varices. J Hepatol. 2016 Nov;65(5):899-905. doi: 10.1016/j.jhep.2016.06.021. Epub 2016 Jul 5. |
| 23058320 | Background | Berzigotti A, Seijo S, Arena U, Abraldes JG, Vizzutti F, Garcia-Pagan JC, Pinzani M, Bosch J. Elastography, spleen size, and platelet count identify portal hypertension in patients with compensated cirrhosis. Gastroenterology. 2013 Jan;144(1):102-111.e1. doi: 10.1053/j.gastro.2012.10.001. Epub 2012 Oct 8. |
| 26212020 | Background | Ding NS, Nguyen T, Iser DM, Hong T, Flanagan E, Wong A, Luiz L, Tan JY, Fulforth J, Holmes J, Ryan M, Bell SJ, Desmond PV, Roberts SK, Lubel J, Kemp W, Thompson AJ. Liver stiffness plus platelet count can be used to exclude high-risk oesophageal varices. Liver Int. 2016 Feb;36(2):240-5. doi: 10.1111/liv.12916. Epub 2015 Sep 6. |
| 28696510 | Background | Augustin S, Pons M, Maurice JB, Bureau C, Stefanescu H, Ney M, Blasco H, Procopet B, Tsochatzis E, Westbrook RH, Bosch J, Berzigotti A, Abraldes JG, Genesca J. Expanding the Baveno VI criteria for the screening of varices in patients with compensated advanced chronic liver disease. Hepatology. 2017 Dec;66(6):1980-1988. doi: 10.1002/hep.29363. Epub 2017 Oct 30. |
| 29495113 | Background | Bae J, Sinn DH, Kang W, Gwak GY, Choi MS, Paik YH, Lee JH, Koh KC, Paik SW. Validation of the Baveno VI and the expanded Baveno VI criteria to identify patients who could avoid screening endoscopy. Liver Int. 2018 Aug;38(8):1442-1448. doi: 10.1111/liv.13732. Epub 2018 Mar 25. |
| 36252870 | Derived | Huang Y, Li J, Zheng T, Ji D, Wong YJ, You H, Gu Y, Li M, Zhao L, Li S, Geng S, Yang N, Chen G, Wang Y, Kumar M, Jindal A, Qin W, Chen Z, Xin Y, Jiang Z, Chi X, Cheng J, Zhang M, Liu H, Lu M, Li L, Zhang Y, Pu C, Ma D, He Q, Tang S, Wang C, Liu S, Wang J, Liu Y, Liu C, Liu H, Sarin SK, Xiaolong Qi. Development and validation of a machine learning-based model for varices screening in compensated cirrhosis (CHESS2001): an international multicenter study. Gastrointest Endosc. 2023 Mar;97(3):435-444.e2. doi: 10.1016/j.gie.2022.10.018. Epub 2022 Oct 14. |
| 36121707 | Derived | Huang Y, Zhao L, He R, Li S, Liu C, Qi X, Li J. A strategy for varices screening based on acoustic radiation force impulse combined with platelet (CHESS2001): An alternative of Baveno VI criteria. Hepatol Commun. 2022 Nov;6(11):3154-3162. doi: 10.1002/hep4.2076. Epub 2022 Sep 19. |
| 35572990 | Derived | Huang Y, Zhang W, Xiang H, Liu Y, Yuan L, Zhang L, Hu S, Xia D, Li J, Gao M, Wang X, Qi X, Peng L, Song Y, Zhou X, Zeng J, Tan X, Deng M, Fang H, Qi S, He S, He Y, Ye B, Wu W, Dang T, Shao J, Wei W, Hu J, Yong X, He C, Bao J, Zhang Y, Zhang G, Ji R, Bo Y, Yan W, Li H, Wang Y, Li M, Wang F, Lian J, Liu C, Cao P, Liu Z, Liu A, Zhao L, Li S, Wu Y, Gu Y, Wang Y, Fang Y, Jiang P, Wu B, Liu C, Qi X. Treatment Strategies in Emergency Endoscopy for Acute Esophageal Variceal Bleeding (CHESS1905): A Nationwide Cohort Study. Front Med (Lausanne). 2022 Apr 27;9:872881. doi: 10.3389/fmed.2022.872881. eCollection 2022. |