NCT04307264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

March 18, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

March 11, 2020

Last Update Submit

April 23, 2023

Conditions

Compensated Advanced Chronic Liver DiseaseVarices Needing Treatment

Keywords

Varices needing treatmentNon-invasiveLiver stiffnessPlatelet count

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Accuracy of LSPS model

    1 day

Study Arms (1)

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).

Procedure: Esophagogasrtoduodendoscopy, liver stiffness measurement

Interventions

Esophagogasrtoduodendoscopy, liver stiffness measurementPROCEDURE

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

Overall eligible participants

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with compensated advanced chronic liver disease

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Ankang Central Hospital

Ankang, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

the Seventh Medical Center of PLA General Hospital

Beijing, China

Location

Dalian Sixth People's Hospital

Dalian, China

Location

Zhujiang Hospital

Guangzhou, China

Location

The First Hospital of Lanzhou University

Lanzhou, China

Location

The Central Hospital of Lishui City

Lishui, China

Location

Guangxi Zhuang Autonomous Region

Nanning, China

Location

Shanghai Tongji Hospital

Shanghai, China

Location

Sixth People's Hospital of Shenyang

Shenyang, China

Location

Tianjin Second People's Hospital

Tianjin, China

Location

Xingtai People's Hospital

Xingtai, China

Location

Sir Run Run Shaw Hospital

Zhejiang, China

Location

The Affiliated Third Hospital of Jiangsu University

Zhenjiang, China

Location

the Fifth Affiliated Hospital of Zunyi Medical University

Zhuhai, China

Location

Related Publications (11)

  • 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.

    PMID: 30215362BACKGROUND

  • 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.

    PMID: 25164003BACKGROUND

  • 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.

    PMID: 26047908BACKGROUND

  • 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.

    PMID: 27388923BACKGROUND

  • 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.

    PMID: 23058320BACKGROUND

  • 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.

    PMID: 26212020BACKGROUND

  • 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.

    PMID: 28696510BACKGROUND

  • 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.

    PMID: 29495113BACKGROUND

  • 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.

    PMID: 36252870DERIVED

  • 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.

    PMID: 36121707DERIVED

  • 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.

    PMID: 35572990DERIVED

Study Officials

  • 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.

    The Sixth People's Hospital of Shenyang

    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.

    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.

    The Affiliated Third Hospital of Jiangsu University

    PRINCIPAL INVESTIGATOR

  • Chuxiao Shao, M.D.

    The Central Hospital of Lishui City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Institute of Portal Hypertension

Study Record Dates

First Submitted

March 11, 2020

First Posted

March 13, 2020

Study Start

March 18, 2020

Primary Completion

March 17, 2023

Study Completion

March 17, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

CN(15)