Compensated Liver CirrhosisNCT03778775
Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Compensated Cirrhosis (Pan-CHESS1801)
An observational study of Compensated Liver Cirrhosis and Gastroesophageal Varices Bleeding, run by Nanfang Hospital, Southern Medical University at 16 sites in 5 countries.
Trial summary
Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Compensated Liver Cirrhosis, Gastroesophageal Varices Bleeding
- What is being tested?
- Liver sitffness measurement
- How many people
- 200 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 14 Dec 2018to 13 Mar 2022
- 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: Participants with compensated liver cirrhosis
Who may be able to join
- age 18-75 years;
- confirmed liver cirrhosis based on liver biopsy or clinical findings;
- compensated liver cirrhosis;
- scheduled to undergo esophagogastroduodenoscopy;
- estimated survival time> 24 months, and model for end-stage liver disease (MELD) score< 19;
- with written informed consent.
Who cannot join
- contradictions for esophagogastroduodenoscopy;
- body mass index> 35 kg/m2;
- presence of decompensation events (e.g. ascites, variceal bleeding, hepatic encephalopathy, etc.);
- previous esophageal variceal banding legation or transjugular intrahepatic portosystemic shunt;
- current use of non-selective beta-blockers;
- with portal vein thrombosis or hepatocellular carcinoma;
- non-cirrhotic portal hypertension;
- pregnancy or unknown pregnancy status.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
China12 sites, 12 recruiting
- Recruiting
The Seventh Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000
Shuai Wang, M.D.
Shuai Wang, M.D.
- Not yet recruiting
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Guofeng Chen
Guofeng Chen, M.D.
- Not yet recruiting
Beijing Tsinghua Changgung Hospital of Tsinghua University
Beijing, Beijing Municipality, 102218
Jiahong Dong
Jiahong Dong, M.D.
- Recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou, Guangdong, 510000
Hua Mao
Hua Mao, M.D.
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong
Chunqing Zhang, M.D.
Chunqing Zhang, M.D.
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu
Xiaorong Mao, M.D.
Xun Li, M.D.
- Not yet recruiting
The Central Hospital of Lishui City
Lishui, Zhejiang
Jiansong Ji, M.D.
Jiansong Ji, M.D.
- Not yet recruiting
Shunde Hospital, Southern Medical University
Shunde, Guangdong
Guoping Du, M.D.
Guoping Du, M.D.
- Not yet recruiting
Wuhan Union Hospital, China
Wuhan, Hubei, 430022
Ling Yang, M.D.
Xiaohua Hou, M.D.
- Not yet recruiting
Xijing Hospital of Digestive Diseases
Xi’an, Shanxi
Ying Han, M.D.
Ying Han, M.D.
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi
Zongfang Li, M.D.
Zongfang Li, M.D.
- Not yet recruiting
Xingtai People's Hospital
Xingtai, Hebei
Dengxiang Liu, M.D.
Dengxiang Liu, M.D.
Indonesia1 site, 1 recruiting
- Not yet recruiting
Medistra Hospital, University of Indonesia
Jakarta
Cosmas Rinaldi A. Lesmana, M.D.
Cosmas Rinaldi A. Lesmana, M.D.
Japan1 site, 1 recruiting
- Not yet recruiting
Osaka City University
Osaka
Norifumi Kawada, M.D.
Norifumi Kawada, M.D.
Thailand1 site, 1 recruiting
- Not yet recruiting
Department of Medicine, Chulalongkorn University
Bangkok
Sombat Treeprasertsuk, M.D.
Sombat Treeprasertsuk, M.D.
Turkey (Türkiye)1 site, 1 recruiting
- Not yet recruiting
Ankara University School of Medicine
Ankara
Necati Örmeci, M.D.
Necati Örmeci, M.D.
About this study
Official title: Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Patients With Compensated Cirrhosis (Pan-CHESS1801): An International Multicenter Study
Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (varies needing treatment), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice, especially in compensated cirrhotic patients.
The important role of transient elastography for defining the presence of high-risk varices was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than 150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score) were shown to have potentials in distinguish the absence of high-risk gastroesophageal varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in Asia-Pacific population.
FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient elastography based on a two-dimensional image-guided system to ensure the precise orientation. In the present study, the investigators aim to conduct an international prospective diagnostic trial with 16 sites to develop and validate the diagnostic performance of FibroTouch-based models for assessing risk of gastroesophageal varices bleeding in compensated cirrhosis.
Read the detailed description
Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (varies needing treatment), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice, especially in compensated cirrhotic patients.
The important role of transient elastography for defining the presence of high-risk varices was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than 150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score) were shown to have potentials in distinguish the absence of high-risk gastroesophageal varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in Asia-Pacific population.
FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient elastography based on a two-dimensional image-guided system to ensure the precise orientation. In the present study, the investigators aim to conduct an international prospective diagnostic trial with 16 sites (Beijing Tsinghua Changgung Hospital, Lanzhou University, The Fifth Medical Center of Chinese PLA General Hospital, Xijing Hospital of Digestive Diseases Wuhan Union Hospital, Zhujiang Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Central Hospital of Lishui City, Xingtai People's Hospital, The Seventh Medical Center of Chinese PLA General Hospital Shandong Provincial Hospital, Shunde Hospital, Southern Medical University Medistra Hospital; University of Indonesia, Ankara University School of Medicine, Osaka City University, Chulalongkorn University) to develop and validate the diagnostic performance of FibroTouch-based models for assessing risk of gastroesophageal varices bleeding in compensated cirrhosis.
- Being tested
- Liver sitffness measurement
- Keywords
- Transient elastography, Gastroesophageal varices bleeding, Varices needing treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver sitffness measurementDiagnostic test
Also called Esophagogastroduodenoscopy
Liver sitffness measurement is performed by FibroTouch, a new-generation of transient elastography with the tesing interval between liver sitffness measurement and esophagogastroduodenoscopy less than one week.
| Study group | Role | What they receive |
|---|---|---|
| Overall eligible participants | Eligible participants will receive standard esophagogastroduodenoscopy and liver stiffness measurement by FibroTouch. Receives: Diagnostic Test: Liver sitffness measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding
Diagnostic accuracy of FibroTouch-based models to determine the high-risk or low-risk of variceal bleeding with esophagogastroduodenoscopy as the reference standard
Measured: 1 day
Secondary outcomes (2)
The correlation between FibroTouch-based models and HVPG
The correlation between FibroTouch-based models and hepatic venous pressure gradient (HVPG)
Measured: 1 day
Diagnostic accuracy of FibroTouch-based models for the decompensated events of cirrhotic portal hypertension
Diagnostic accuracy of FibroTouch-based models to determine the presence or absence of decompensated events (e.g. first variceal bleeding) within 1-year follow-up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start14 Dec 2018
- Primary completion13 Jun 2021
- Study completion13 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Compensated Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital, LanZhou University, Beijing 302 Hospital, Xijing Hospital of Digestive Diseases, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhujiang Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Central Hospital of Lishui City, Xingtai People's Hospital, Seventh Medical Center of PLA Army General Hospital, Shandong Provincial Hospital, Southern Medical University, China, Medistra Hospital, University of Indonesia, Ankara University, Osaka City University, Chulalongkorn University
- Responsible party
- Principal investigator, Xiaolong Qi, Nanfang Hospital, Southern Medical University
- Investigators
- Jiahong Dong, MD, Principal investigator, Beijing Tsinghua Changgeng HospitalXiaolong Qi, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778775
- Sponsor's protocol ID
- Pan-CHESS1801
- Status last verified
- Aug 2021
- First submitted
- 16 Dec 2018
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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 30215362Liu F, Ning Z, Liu Y, Liu D, Tian J, Luo H, An W, Huang Y, Zou J, Liu C, Liu C, Wang L, Liu Z, Qi R, Zuo C, Zhang Q, Wang J, Zhao D, Duan Y, Peng B, Qi X, Zhang Y, Yang Y, Hou J, Dong J, Li Z, Ding H, Zhang Y, Qi X. Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study. EBioMedicine. 2018 Oct;36:151-158. doi: 10.1016/j.ebiom.2018.09.023. Epub 2018 Sep 27.
PubMed 30268833Wang 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 25164003de 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 26047908Berzigotti 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 23058320Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.
PubMed 27298379Zhu Q, Wang W, Zhao J, Al-Asbahi AAM, Huang Y, Du F, Zhou J, Song Y, Xu K, Ye J, Yang L. Transient Elastography Identifies the Risk of Esophageal Varices and Bleeding in Patients With Hepatitis B Virus-Related Liver Cirrhosis. Ultrasound Q. 2018 Sep;34(3):141-147. doi: 10.1097/RUQ.0000000000000373.
PubMed 30020268Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20.
PubMed 30457484
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transient Elastography (FibroTouch) for Assessing Risk of Gastroesophageal Varices Bleeding in Patients With Compensated Cirrhosis (Pan-CHESS1801): An International Multicenter Study
- ClinicalTrials.gov ID
- NCT03778775
- Acronym / sponsor ID
- Pan-CHESS1801
- Keywords
- Transient elastography, Gastroesophageal varices bleeding, Varices needing treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Tsinghua Changgeng Hospital, LanZhou University, Beijing 302 Hospital, Xijing Hospital of Digestive Diseases, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Zhujiang Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Central Hospital of Lishui City, Xingtai People's Hospital, Seventh Medical Center of PLA Army General Hospital, Shandong Provincial Hospital, Southern Medical University, China, Medistra Hospital, University of Indonesia, Ankara University, Osaka City University, Chulalongkorn University
- Study start
- 14 Dec 2018 (actual)
- Primary completion
- 13 Jun 2021 (actual)
- Study completion
- 13 Mar 2022 (estimated)
- First posted
- 19 Dec 2018 (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.
Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (varies needing treatment), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice, especially in compensated cirrhotic patients.
The important role of transient elastography for defining the presence of high-risk varices was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than 150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score) were shown to have potentials in distinguish the absence of high-risk gastroesophageal varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in Asia-Pacific population.
FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient elastography based on a two-dimensional image-guided system to ensure the precise orientation. In the present study, the investigators aim to conduct an international prospective diagnostic trial with 16 sites to develop and validate the diagnostic performance of FibroTouch-based models for assessing risk of gastroesophageal varices bleeding in compensated cirrhosis.
Detailed description
Gastroesophageal varices occurs in approximately half of the patients with liver cirrhosis. Variceal bleeding is the most common lethal complication directly from cirrhotic portal hypertension. The golden standard for diagnosing gastroesophageal varices and evaluating the risk of variceal bleeding is the esophagogastroduodenoscopy. According to the Baveno VI consensus, for those with high-risk varices (varies needing treatment), either non-selective beta blockers or endoscopic band ligation is recommended for the prevention of the first variceal bleeding. However, the invasiveness and uncomfortableness during the esophagogastroduodenoscopy procedure has hindered its routine use in clinical practice, especially in compensated cirrhotic patients.
The important role of transient elastography for defining the presence of high-risk varices was highlighted in the Baveno VI consensus workshop that cirrhotic patients with a liver stiffness measurement (LSM) of less than 20 kPa and a platelet count of greater than 150,000/μL can avoid screening endoscopy. In addition, transient elastography-based models (e.g. LSM combined with platelet count, liver stiffness spleen diameter-to-platelet score) were shown to have potentials in distinguish the absence of high-risk gastroesophageal varices. However, this cutoff value of LSM was validated mainly in cohorts with alcoholic or hepatitis C virus dominated cirrhosis. The unmet need is a precise cutoff to rule out high-risk varices in hepatitis B virus dominated cirrhosis, which is an outstanding issue in Asia-Pacific population.
FibroTouch (Hisky Medical Technologies Co. Ltd, Wuxi, China) is a new-generation of transient elastography based on a two-dimensional image-guided system to ensure the precise orientation. In the present study, the investigators aim to conduct an international prospective diagnostic trial with 16 sites (Beijing Tsinghua Changgung Hospital, Lanzhou University, The Fifth Medical Center of Chinese PLA General Hospital, Xijing Hospital of Digestive Diseases Wuhan Union Hospital, Zhujiang Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, The Central Hospital of Lishui City, Xingtai People's Hospital, The Seventh Medical Center of Chinese PLA General Hospital Shandong Provincial Hospital, Shunde Hospital, Southern Medical University Medistra Hospital; University of Indonesia, Ankara University School of Medicine, Osaka City University, Chulalongkorn University) to develop and validate the diagnostic performance of FibroTouch-based models for assessing risk of gastroesophageal varices bleeding in compensated cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall eligible participants | – | Diagnostic Test: Liver sitffness measurementEligible participants will receive standard esophagogastroduodenoscopy and liver stiffness measurement by FibroTouch. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with compensated liver cirrhosis
Key inclusion criteria (6 listed)
- age 18-75 years;
- confirmed liver cirrhosis based on liver biopsy or clinical findings;
- compensated liver cirrhosis;
- scheduled to undergo esophagogastroduodenoscopy;
- estimated survival time> 24 months, and model for end-stage liver disease (MELD) score< 19;
Key exclusion criteria (8 listed)
- contradictions for esophagogastroduodenoscopy;
- body mass index> 35 kg/m2;
- presence of decompensation events (e.g. ascites, variceal bleeding, hepatic encephalopathy, etc.);
- previous esophageal variceal banding legation or transjugular intrahepatic portosystemic shunt;
- current use of non-selective beta-blockers;
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 |
|---|---|---|
| Liver sitffness measurementAlso: EsophagogastroduodenoscopyLiver sitffness measurement is performed by FibroTouch, a new-generation of transient elastography with the tesing interval between liver sitffness measurement and esophagogastroduodenoscopy less than one week. | Diagnostic test | Overall eligible participants |
Primary outcome
Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding
Time frame: 1 day
Diagnostic accuracy of FibroTouch-based models to determine the high-risk or low-risk of variceal bleeding with esophagogastroduodenoscopy as the reference standard
2 secondary outcomes
The correlation between FibroTouch-based models and HVPG
Time frame: 1 day
Diagnostic accuracy of FibroTouch-based models for the decompensated events of cirrhotic portal hypertension
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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 30268833Liu F, Ning Z, Liu Y, Liu D, Tian J, Luo H, An W, Huang Y, Zou J, Liu C, Liu C, Wang L, Liu Z, Qi R, Zuo C, Zhang Q, Wang J, Zhao D, Duan Y, Peng B, Qi X, Zhang Y, Yang Y, Hou J, Dong J, Li Z, Ding H, Zhang Y, Qi X. Development and validation of a radiomics signature for clinically significant portal hypertension in cirrhosis (CHESS1701): a prospective multicenter study. EBioMedicine. 2018 Oct;36:151-158. doi: 10.1016/j.ebiom.2018.09.023. Epub 2018 Sep 27.
- Background: PubMed 25164003Wang 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.
- 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 23058320Berzigotti 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.
- Background: PubMed 27298379Bhardwaj A, Kedarisetty CK, Vashishtha C, Bhadoria AS, Jindal A, Kumar G, Choudhary A, Shasthry SM, Maiwall R, Kumar M, Bhatia V, Sarin SK. Carvedilol delays the progression of small oesophageal varices in patients with cirrhosis: a randomised placebo-controlled trial. Gut. 2017 Oct;66(10):1838-1843. doi: 10.1136/gutjnl-2016-311735. Epub 2016 Jun 13.
- Background: PubMed 30020268Zhu Q, Wang W, Zhao J, Al-Asbahi AAM, Huang Y, Du F, Zhou J, Song Y, Xu K, Ye J, Yang L. Transient Elastography Identifies the Risk of Esophageal Varices and Bleeding in Patients With Hepatitis B Virus-Related Liver Cirrhosis. Ultrasound Q. 2018 Sep;34(3):141-147. doi: 10.1097/RUQ.0000000000000373.
- Background: PubMed 30457484Qi X, An W, Liu F, Qi R, Wang L, Liu Y, Liu C, Xiang Y, Hui J, Liu Z, Qi X, Liu C, Peng B, Ding H, Yang Y, He X, Hou J, Tian J, Li Z. Virtual Hepatic Venous Pressure Gradient with CT Angiography (CHESS 1601): A Prospective Multicenter Study for the Noninvasive Diagnosis of Portal Hypertension. Radiology. 2019 Feb;290(2):370-377. doi: 10.1148/radiol.2018180425. Epub 2018 Nov 20.
- Individual participant dataSharing planned: Undecided. 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.
Jiahong Dong, MD principal investigator
Beijing Tsinghua Changgeng Hospital
Xiaolong Qi, MD principal investigator
Nanfang Hospital, Southern Medical University
16 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 Liver Cirrhosis and Gastroesophageal Varices Bleeding, run by Nanfang Hospital, Southern Medical University at 16 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 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: status not confirmed, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China, Indonesia, Japan, Thailand, Turkey (Türkiye). 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 (18588602600, qixiaolong@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of FibroTouch-based models for the risk of variceal bleeding (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 NCT03778775, which also lists 8 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 17 Aug 2021.