Compensated Advanced Chronic Liver DiseaseNCT04975477
CHESS-SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease (CHESS2102)
An observational study of Compensated Advanced Chronic Liver Disease, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 7 sites in 5 countries.
Trial summary
Compensated advanced chronic liver disease (cACLD) was associated with a high rate of variceal bleeding, ascites, and hepatic encephalopathy due to portal hypertension. In these patients, esophagogastroduodenoscopy and hepatic venous pressure gradient were recommended methods to evaluate portal hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compensated Advanced Chronic Liver Disease
- What is being tested?
- Esophagogasrtoduodendoscopy and liver stiffness and hepatic venous pressure gradient
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 16 Jul 2021to 16 Aug 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients were fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis.
Who may be able to join
- age more than 18 years;
- fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis
- age more than 18 years;
- fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis
Who cannot join
- prior liver decompensation;
- hepatocellular carcinoma;
- prior liver transplantation;
- portal vein thrombosis;
- antiplatelet or anticoagulation;
- without screening EGD within six months of TE;
Show all 16Show fewer
- incomplete follow-up data.
- HVPG cohort
- prior liver decompensation;
- hepatocellular carcinoma;
- prior liver transplantation;
- portal vein thrombosis;
- antiplatelet or anticoagulation;
- without screening EGD within six months of TE;
- without HVPG measurement;
- non-sinusoidal portal hypertension.
Trial locations and contacts
7 sites in 5 countries.
Chuan Liu, MD contact
7 sites in 5 countries
China2 sites
Ruijin Hospital
Shanghai
Qing Xie, MD, xieqingrjh@163.com
Tianjin Second People's Hospital
Tianjin
Jia Li, MD, 18622663700@163.com
Japan2 sites
Ehime University Graduate School of Medicine
Matsuyama
Hyogo College of Medicine
Nishinomiya
Hirayuki Enomoto, MD, enomoto@hyo-med.ac.jp
India1 site
Institute of Liver and Biliary Sciences
New Delhi
Shiv Sarin, MD, shivsarin@gmail.com
South Korea1 site
Korea University Ansan Hospital
Gyeonggi-do
Hyung Joon Yim, MD, gudwns21@korea.ac.kr
About this study
Official title: CHESS-SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease: an International Multicenter Study (CHESS2102)
Compensated advanced chronic liver disease (cACLD) was associated with a high rate of variceal bleeding, ascites, and hepatic encephalopathy due to portal hypertension. In these patients, esophagogastroduodenoscopy and hepatic venous pressure gradient were recommended methods to evaluate portal hypertension. However, non-invasive predictors of outcomes to stratify care remains needed. Although the updated EASL guideline has recommended that patients with liver stiffness >20kPa or platelets <150*10^9/L had the high risk of decompensation, the criteria remains to be validated. This international multicenter study aims to develop a novel CHESS-SAVE score to further predict the risk of liver decompensation in cACLD patients.
Read the detailed description
Compensated advanced chronic liver disease (cACLD) was associated with a high rate of variceal bleeding, ascites, and hepatic encephalopathy due to portal hypertension. In these patients, esophagogastroduodenoscopy and hepatic venous pressure gradient were recommended methods to evaluate portal hypertension. However, non-invasive predictors of outcomes to stratify care remains needed. Although the updated EASL guideline has recommended that patients with liver stiffness >20kPa or platelets <150*10^9/L had the high risk of decompensation, the criteria remains to be validated. This international multicenter study initialed and enrolled by Chinese Portal Hypertension Alliance (CHESS) aims to develop a novel CHESS-SAVE score to further predict the risk of liver decompensation in cACLD patients.
- Being tested
- Esophagogasrtoduodendoscopy and liver stiffness, hepatic venous pressure gradient
- Keywords
- liver stiffness, platelets, albumin, varices, compensated cirrhosis
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagogasrtoduodendoscopy and liver stiffnessProcedure or surgery
Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.
hepatic venous pressure gradientProcedure or surgery
A method was used to evaluate portal pressure.
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | A cohort was used to develop the novel score for predicting liver decompensation Receives: Procedure: Esophagogasrtoduodendoscopy and liver stiffness | |
| Validation cohort | A cohort was used to validate the performance of novel score for predicting liver decompensation Receives: Procedure: Esophagogasrtoduodendoscopy and liver stiffness | |
| Exploratory cohort | A cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension Receives: Procedure: Esophagogasrtoduodendoscopy and liver stiffness; Procedure: hepatic venous pressure gradient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the CHESS-SAVE score for predicting liver decompensation
To assess the accuracy of the CHESS-SAVE score to predict liver decompensation in patients with compensated advanced chronic liver disease
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start16 Jul 2021 (estimated)
- Primary completion16 Aug 2021 (estimated)
- Study completion16 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Compensated Advanced Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Collaborators
- LanZhou University, Institute of Liver and Biliary Sciences (ILBS), Zagazig University, Korea University, Ehime University Graduate School of Medicine, Hyogo Medical University, Tianjin Second People's Hospital, Ruijin Hospital
- Responsible party
- Principal investigator, Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975477
- Sponsor's protocol ID
- CHESS2102
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 30215362de 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 26047908Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2019 Apr 20;393(10181):1597-1608. doi: 10.1016/S0140-6736(18)31875-0. Epub 2019 Mar 22.
PubMed 30910320Sarin SK, Lamba GS, Kumar M, Misra A, Murthy NS. Comparison of endoscopic ligation and propranolol for the primary prevention of variceal bleeding. N Engl J Med. 1999 Apr 1;340(13):988-93. doi: 10.1056/NEJM199904013401302.
PubMed 10099140Cholongitas E, Papatheodoridis GV, Vangeli M, Terreni N, Patch D, Burroughs AK. Systematic review: The model for end-stage liver disease--should it replace Child-Pugh's classification for assessing prognosis in cirrhosis? Aliment Pharmacol Ther. 2005 Dec;22(11-12):1079-89. doi: 10.1111/j.1365-2036.2005.02691.x.
PubMed 16305721Chen RC, Cai YJ, Wu JM, Wang XD, Song M, Wang YQ, Zheng MH, Chen YP, Lin Z, Shi KQ. Usefulness of albumin-bilirubin grade for evaluation of long-term prognosis for hepatitis B-related cirrhosis. J Viral Hepat. 2017 Mar;24(3):238-245. doi: 10.1111/jvh.12638. Epub 2016 Nov 14.
PubMed 27862671Abraldes JG, Bureau C, Stefanescu H, Augustin S, Ney M, Blasco H, Procopet B, Bosch J, Genesca J, Berzigotti A; Anticipate Investigators. Noninvasive tools and risk of clinically significant portal hypertension and varices in compensated cirrhosis: The "Anticipate" study. Hepatology. 2016 Dec;64(6):2173-2184. doi: 10.1002/hep.28824. Epub 2016 Oct 27.
PubMed 27639071Thabut D, Bureau C, Layese R, Bourcier V, Hammouche M, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, De Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Goria O, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Attali P, Bacq Y, Wartelle-Bladou C, Dao T, Pilette C, Silvain C, Christidis C, Capron D, Bernard-Chabert B, Hillaire S, Di Martino V, Sutton A, Audureau E, Roudot-Thoraval F, Nahon P; ANRS CO12 CirVir group. Validation of Baveno VI Criteria for Screening and Surveillance of Esophageal Varices in Patients With Compensated Cirrhosis and a Sustained Response to Antiviral Therapy. Gastroenterology. 2019 Mar;156(4):997-1009.e5. doi: 10.1053/j.gastro.2018.11.053. Epub 2019 Feb 13.
PubMed 30768988European Association for the Study of the Liver. EASL Clinical Practice Guidelines on non-invasive tests for evaluation of liver disease severity and prognosis - 2021 update. J Hepatol. 2021 Sep;75(3):659-689. doi: 10.1016/j.jhep.2021.05.025. Epub 2021 Jun 21.
PubMed 34166721Liu C, Cao Z, Yan H, Wong YJ, Xie Q, Hirooka M, Enomoto H, Kim TH, Hanafy AS, Liu Y, Huang Y, Li X, Kang N, Koizumi Y, Hiasa Y, Nishimura T, Iijima H, Jung YK, Yim HJ, Guo Y, Zhang L, Ma J, Kumar M, Jindal A, Teh KB, Sarin SK, Qi X. A Novel SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease (CHESS2102): An International Multicenter Cohort Study. Am J Gastroenterol. 2022 Oct 1;117(10):1605-1613. doi: 10.14309/ajg.0000000000001873. Epub 2022 Jun 15.
PubMed 35973168
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHESS-SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease: an International Multicenter Study (CHESS2102)
- ClinicalTrials.gov ID
- NCT04975477
- Acronym / sponsor ID
- CHESS2102
- Keywords
- liver stiffness, platelets, albumin, varices, compensated cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Collaborators
- LanZhou University, Institute of Liver and Biliary Sciences (ILBS), Zagazig University, Korea University, Ehime University Graduate School of Medicine, Hyogo Medical University, Tianjin Second People's Hospital, Ruijin Hospital
- Study start
- 16 Jul 2021 (estimated)
- Primary completion
- 16 Aug 2021 (estimated)
- Study completion
- 16 Aug 2021 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compensated advanced chronic liver disease (cACLD) was associated with a high rate of variceal bleeding, ascites, and hepatic encephalopathy due to portal hypertension. In these patients, esophagogastroduodenoscopy and hepatic venous pressure gradient were recommended methods to evaluate portal hypertension. However, non-invasive predictors of outcomes to stratify care remains needed. Although the updated EASL guideline has recommended that patients with liver stiffness >20kPa or platelets <150*10^9/L had the high risk of decompensation, the criteria remains to be validated. This international multicenter study aims to develop a novel CHESS-SAVE score to further predict the risk of liver decompensation in cACLD patients.
Detailed description
Compensated advanced chronic liver disease (cACLD) was associated with a high rate of variceal bleeding, ascites, and hepatic encephalopathy due to portal hypertension. In these patients, esophagogastroduodenoscopy and hepatic venous pressure gradient were recommended methods to evaluate portal hypertension. However, non-invasive predictors of outcomes to stratify care remains needed. Although the updated EASL guideline has recommended that patients with liver stiffness >20kPa or platelets <150*10^9/L had the high risk of decompensation, the criteria remains to be validated. This international multicenter study initialed and enrolled by Chinese Portal Hypertension Alliance (CHESS) aims to develop a novel CHESS-SAVE score to further predict the risk of liver decompensation in cACLD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Procedure: Esophagogasrtoduodendoscopy and liver stiffnessA cohort was used to develop the novel score for predicting liver decompensation |
| Validation cohort | – | Procedure: Esophagogasrtoduodendoscopy and liver stiffnessA cohort was used to validate the performance of novel score for predicting liver decompensation |
| Exploratory cohort | – | Procedure: Esophagogasrtoduodendoscopy and liver stiffness, Procedure: hepatic venous pressure gradientA cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis.
Key inclusion criteria (4 listed)
- age more than 18 years;
- fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis
- age more than 18 years;
- fulfilled diagnosis of cACLD based on radiological, histological features of liver cirrhosis
Key exclusion criteria (16 listed)
- prior liver decompensation;
- hepatocellular carcinoma;
- prior liver transplantation;
- portal vein thrombosis;
- antiplatelet or anticoagulation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophagogasrtoduodendoscopy and liver stiffnessTime frame between elastography measurement and esophagogastroduodendoscopy is within 6 months. | Procedure or surgery | Exploratory cohort, Training cohort, Validation cohort |
| hepatic venous pressure gradientA method was used to evaluate portal pressure. | Procedure or surgery | Exploratory cohort |
Primary outcome
Accuracy of the CHESS-SAVE score for predicting liver decompensation
Time frame: 3 years
To assess the accuracy of the CHESS-SAVE score to predict liver decompensation in patients with compensated advanced chronic liver disease
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Background: PubMed 30215362Qi 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.
- Background: PubMed 26047908de 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.
- Background: PubMed 30910320Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2019 Apr 20;393(10181):1597-1608. doi: 10.1016/S0140-6736(18)31875-0. Epub 2019 Mar 22.
- Background: PubMed 10099140Sarin SK, Lamba GS, Kumar M, Misra A, Murthy NS. Comparison of endoscopic ligation and propranolol for the primary prevention of variceal bleeding. N Engl J Med. 1999 Apr 1;340(13):988-93. doi: 10.1056/NEJM199904013401302.
- Background: PubMed 16305721Cholongitas E, Papatheodoridis GV, Vangeli M, Terreni N, Patch D, Burroughs AK. Systematic review: The model for end-stage liver disease--should it replace Child-Pugh's classification for assessing prognosis in cirrhosis? Aliment Pharmacol Ther. 2005 Dec;22(11-12):1079-89. doi: 10.1111/j.1365-2036.2005.02691.x.
- Background: PubMed 27862671Chen RC, Cai YJ, Wu JM, Wang XD, Song M, Wang YQ, Zheng MH, Chen YP, Lin Z, Shi KQ. Usefulness of albumin-bilirubin grade for evaluation of long-term prognosis for hepatitis B-related cirrhosis. J Viral Hepat. 2017 Mar;24(3):238-245. doi: 10.1111/jvh.12638. Epub 2016 Nov 14.
- Background: PubMed 27639071Abraldes JG, Bureau C, Stefanescu H, Augustin S, Ney M, Blasco H, Procopet B, Bosch J, Genesca J, Berzigotti A; Anticipate Investigators. Noninvasive tools and risk of clinically significant portal hypertension and varices in compensated cirrhosis: The "Anticipate" study. Hepatology. 2016 Dec;64(6):2173-2184. doi: 10.1002/hep.28824. Epub 2016 Oct 27.
- Background: PubMed 30768988Thabut D, Bureau C, Layese R, Bourcier V, Hammouche M, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, De Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Goria O, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Attali P, Bacq Y, Wartelle-Bladou C, Dao T, Pilette C, Silvain C, Christidis C, Capron D, Bernard-Chabert B, Hillaire S, Di Martino V, Sutton A, Audureau E, Roudot-Thoraval F, Nahon P; ANRS CO12 CirVir group. Validation of Baveno VI Criteria for Screening and Surveillance of Esophageal Varices in Patients With Compensated Cirrhosis and a Sustained Response to Antiviral Therapy. Gastroenterology. 2019 Mar;156(4):997-1009.e5. doi: 10.1053/j.gastro.2018.11.053. Epub 2019 Feb 13.
- Background: PubMed 34166721European Association for the Study of the Liver. EASL Clinical Practice Guidelines on non-invasive tests for evaluation of liver disease severity and prognosis - 2021 update. J Hepatol. 2021 Sep;75(3):659-689. doi: 10.1016/j.jhep.2021.05.025. Epub 2021 Jun 21.
- Derived from this study: PubMed 35973168Liu C, Cao Z, Yan H, Wong YJ, Xie Q, Hirooka M, Enomoto H, Kim TH, Hanafy AS, Liu Y, Huang Y, Li X, Kang N, Koizumi Y, Hiasa Y, Nishimura T, Iijima H, Jung YK, Yim HJ, Guo Y, Zhang L, Ma J, Kumar M, Jindal A, Teh KB, Sarin SK, Qi X. A Novel SAVE Score to Stratify Decompensation Risk in Compensated Advanced Chronic Liver Disease (CHESS2102): An International Multicenter Cohort Study. Am J Gastroenterol. 2022 Oct 1;117(10):1605-1613. doi: 10.14309/ajg.0000000000001873. Epub 2022 Jun 15.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuan Liu, MD contact
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compensated Advanced Chronic Liver Disease, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 7 sites in 5 countries.
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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China, Japan, Egypt, India, South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Qi, MD (+8618588602600 ext. +8618588602600, qixiaolong@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the CHESS-SAVE score for predicting liver decompensation (time frame: 3 years). 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 NCT04975477, which also lists 10 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 23 Jul 2021.