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

NCT ID: NCT04307264

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-18
• Study Completion Date: 2023-03-17

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.

Conditions

Compensated Advanced Chronic Liver Disease; Varices Needing Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Esophagogasrtoduodendoscopy, liver stiffness measurement

Intervention Type: PROCEDURE

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

Interventions

Esophagogasrtoduodendoscopy, liver stiffness measurement

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LanZhou University

OTHER

Sponsor Role: collaborator

Tianjin Second People's Hospital

OTHER

Sponsor Role: collaborator

The Sixth People's Hospital of Shenyang

OTHER

Sponsor Role: collaborator

Ankang Central Hospital

OTHER

Sponsor Role: collaborator

Guangxi Zhuang Autonomous Region

UNKNOWN

Sponsor Role: collaborator

Dalian Sixth People's Hospital

UNKNOWN

Sponsor Role: collaborator

Xingtai People's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: collaborator

Seventh Medical Center of PLA Army General Hospital

OTHER

Sponsor Role: collaborator

Zhujiang Hospital

OTHER

Sponsor Role: collaborator

The Fifth Affiliated Hospital of Zunyi Medical College

OTHER

Sponsor Role: collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: collaborator

Beijing Tsinghua Changgeng Hospital

OTHER

Sponsor Role: collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role: collaborator

The Affiliated Third Hospital of Jiangsu University

UNKNOWN

Sponsor Role: collaborator

Hepatopancreatobiliary Surgery Institute of Gansu Province

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong Qi

Director, Institute of Portal Hypertension

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiahong Dong, M.D.

Role: STUDY_CHAIR

Beijing Tsinghua Changgeng Hospital

Xiaolong Qi, M.D.

Role: STUDY_CHAIR

LanZhou University

Liting Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

LanZhou University

Lin Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Changgeng Hospital

Fengmei Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tianjin Second People's Hospital

Ye Gu, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Sixth People's Hospital of Shenyang

Zicheng Jiang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ankang Central Hospital

Guo Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Guangxi Zhuang Autonomous Region

Yong Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dalian Sixth People's Hospital

Dengxiang Liu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xingtai People's Hospital

Li Yang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Tongji Hospital, Tongji University School of Medicine

Shuai Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seventh Medical Center of PLA Army General Hospital

Hua Mao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital

Chaohui He, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Fifth Affiliated Hospital of Zunyi Medical College

Weiling Hu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Shengqiang Zou, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Third Hospital of Jiangsu University

Chuxiao Shao, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Central Hospital of Lishui City

Locations

Ankang Central Hospital

Ankang, , China

Beijing Tsinghua Changgung Hospital

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

Countries

China

References

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Other Identifiers

CHESS2001

Identifier Type: -

Identifier Source: org_study_id