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Compensated Advanced Chronic Liver DiseaseNCT04307264

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

An observational study of Compensated Advanced Chronic Liver Disease and Varices Needing Treatment, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 15 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Esophagogasrtoduodendoscopy, liver stiffness measurement
Type of treatment
Surgery or procedure
How many people
2,000 participants
Where
15 sitesChina
Study dates
18 Mar 2020to 17 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient with compensated advanced chronic liver disease

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

China15 sites

  • Ankang Central Hospital

    Ankang

  • Beijing Tsinghua Changgung Hospital

    Beijing

  • the Seventh Medical Center of PLA General Hospital

    Beijing

  • Dalian Sixth People's Hospital

    Dalian

  • Zhujiang Hospital

    Guangzhou

  • The First Hospital of Lanzhou University

    Lanzhou

  • The Central Hospital of Lishui City

    Lishui

  • Guangxi Zhuang Autonomous Region

    Nanning

  • Shanghai Tongji Hospital

    Shanghai

  • Sixth People's Hospital of Shenyang

    Shenyang

  • Tianjin Second People's Hospital

    Tianjin

  • Xingtai People's Hospital

    Xingtai

  • Sir Run Run Shaw Hospital

    Zhejiang

  • The Affiliated Third Hospital of Jiangsu University

    Zhenjiang

  • the Fifth Affiliated Hospital of Zunyi Medical University

    Zhuhai

Other trials in China

About this study

Official title: Development and Validation of CHESS Criteria for the Screening of Varices in Patients With Compensated Advanced Chronic Liver Disease (CHESS2001/APPHA2001)

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.

Read the 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.

Being tested
Esophagogasrtoduodendoscopy, liver stiffness measurement
Keywords
Varices needing treatment, Non-invasive, Liver stiffness, Platelet count

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Esophagogasrtoduodendoscopy, liver stiffness measurementProcedure or surgery

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

Study groups in NCT04307264
Study groupRoleWhat they receive
Overall eligible participantsEligible participants will receive standard esophagogasrtoduodendoscopy, liver stiffness measurement and serological examination (platelet count, alanine aminotransferase, aspartate aminotransferase, total bilirubin, Prothrombin time, albumin).
Receives: Procedure: Esophagogasrtoduodendoscopy, liver stiffness measurement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 day

Secondary outcomes (1)

  1. 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

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2020
  2. Study start18 Mar 2020
  3. Primary completion17 Mar 2023
  4. Study completion17 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04307264
Sponsor's protocol ID
CHESS2001
Status last verified
Apr 2023
First submitted
11 Mar 2020
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30215362

  • 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.

    PubMed 25164003

  • 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.

    PubMed 26047908

  • 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.

    PubMed 27388923

  • 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.

    PubMed 23058320

  • 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.

    PubMed 26212020

  • 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.

    PubMed 28696510

  • 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.

    PubMed 29495113

  • 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.

    PubMed 36252870

  • 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.

    PubMed 36121707

  • 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.

    PubMed 35572990

Questions about this trial

What is this clinical trial studying?

An observational study of Compensated Advanced Chronic Liver Disease and Varices Needing Treatment, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of CHESS criteria (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04307264, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.

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