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

NCT04307264 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2000

Last updated 2023-04-25

No results posted yet for this study

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.

Conditions

  • Compensated Advanced Chronic Liver Disease
  • Varices Needing Treatment

Interventions

PROCEDURE

Esophagogasrtoduodendoscopy, liver stiffness measurement

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

Sponsors & Collaborators

  • LanZhou University

    collaborator OTHER
  • Tianjin Second People's Hospital

    collaborator OTHER
  • The Sixth People's Hospital of Shenyang

    collaborator OTHER
  • Ankang Central Hospital

    collaborator OTHER
  • Guangxi Zhuang Autonomous Region

    collaborator UNKNOWN
  • Dalian Sixth People's Hospital

    collaborator UNKNOWN
  • Xingtai People's Hospital

    collaborator OTHER
  • Shanghai Tongji Hospital, Tongji University School of Medicine

    collaborator OTHER
  • Seventh Medical Center of PLA Army General Hospital

    collaborator OTHER
  • Zhujiang Hospital

    collaborator OTHER
  • The Fifth Affiliated Hospital of Zunyi Medical College

    collaborator OTHER
  • Sir Run Run Shaw Hospital

    collaborator OTHER
  • Beijing Tsinghua Changgeng Hospital

    collaborator OTHER
  • The Central Hospital of Lishui City

    collaborator OTHER
  • The Affiliated Third Hospital of Jiangsu University

    collaborator UNKNOWN
  • Hepatopancreatobiliary Surgery Institute of Gansu Province

    lead OTHER

Principal Investigators

  • Jiahong Dong, M.D. · Beijing Tsinghua Changgeng Hospital

  • Xiaolong Qi, M.D. · LanZhou University

  • Liting Zhang, M.D. · LanZhou University

  • Lin Zhang, M.D. · Beijing Tsinghua Changgeng Hospital

  • Fengmei Wang, M.D. · Tianjin Second People's Hospital

  • Ye Gu, M.D. · The Sixth People's Hospital of Shenyang

  • Zicheng Jiang, M.D. · Ankang Central Hospital

  • Guo Zhang, M.D. · Guangxi Zhuang Autonomous Region

  • Yong Zhang, M.D. · Dalian Sixth People's Hospital

  • Dengxiang Liu, M.D. · Xingtai People's Hospital

  • Li Yang, M.D. · Shanghai Tongji Hospital, Tongji University School of Medicine

  • Shuai Wang, M.D. · Seventh Medical Center of PLA Army General Hospital

  • Hua Mao, M.D. · Zhujiang Hospital

  • Chaohui He, M.D. · The Fifth Affiliated Hospital of Zunyi Medical College

  • Weiling Hu, M.D. · Sir Run Run Shaw Hospital

  • Shengqiang Zou, M.D. · The Affiliated Third Hospital of Jiangsu University

  • Chuxiao Shao, M.D. · The Central Hospital of Lishui City

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2023-03-17
Completion
2023-03-17

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307264 on ClinicalTrials.gov