MR-based Models for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)
NCT ID: NCT03766880
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
175 participants
INTERVENTIONAL
2018-12-04
2019-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is a multi-center diagnostic trial conducted at high-volume liver centres designed to determine the accuracy of MR-based models (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis. Transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Virtual Hepatic Venous Pressure Gradient (vHVPG) With CT Angiography (CHESS1601)
NCT02842697
Serum Biomarkers for Portal Hypertension in Cirrhosis (Pan-CHESS1802)
NCT03713606
HVPG-guided Laparoscopic Versus Endoscopic Therapy for Variceal Rebleeding in Portal Hypertension: A Multicenter Randomized Controlled Trial (CHESS1803)
NCT03783065
CHESS Criteria for Varices Screening in Compensated Advanced Chronic Liver Disease (CHESS2001/APPHA2001)
NCT04307264
The Effect of Monitoring PVP on Clinical Outcomes in Patients With PH
NCT04820166
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a multi-center diagnostic trial conducted at high-volume liver centres (Zhongda Hospital, Medical School of Southeast University; Affiliated Lishui Hospital of Zhejiang University; Shandong Provincial Hospital affiliated to Shandong University; Beijing 302 Hospital; Xingtai People's Hospital; Shunde Hospital, Southern Medical University; The First Hospital of Zhengzhou University; Shanghai Public Health Clinical Center, Fudan University; The First Hospital of Lanzhou University; Nanfang Hospital of Southern Medical University; Ankara University School of Medicine) designed to determine the accuracy of MR-based models (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis. Transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter is the gold-standard method to assess the presence of CSPH.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single arm study
Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol.
Transjugular HVPG measurement
By means of catheterization of a hepatic vein with a balloon catheter.
MR imaging
MR images for the post-processing analysis
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Transjugular HVPG measurement
By means of catheterization of a hepatic vein with a balloon catheter.
MR imaging
MR images for the post-processing analysis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* With written informed consent
* Confirmed liver cirrhosis based on liver biopsy or clinical findings
* Scheduled to undergo clinically-indicated transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter
* Has undergone\> MR imaging within 14 days to hepatic vein catheterization
* No hepatic-portal vein interventional therapy between MR imaging and hepatic vein catheterization
Exclusion Criteria
* Unable to comply with breathing or other imaging related instructions resulting in inability to obtain diagnostic quality MR imaging studies
* Contraindication to the injection of contrast agent: pregnancy, lactation, history of allergic reaction to contrast agent injection.
* Prior transjugular intrahepatic portosystem stent-shunt surgery
* Prior devascularization operation
* Has received a liver transplant
* Any active, serious, life-threatening disease
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zhongda Hospital
OTHER
Beijing 302 Hospital
OTHER
Affiliated Lishui Hospital of Zhejiang University
UNKNOWN
Shandong Provincial Hospital
OTHER_GOV
Xingtai People's Hospital
OTHER
The First Hospital of Zhengzhou University
UNKNOWN
Shanghai Public Health Clinical Center, Fudan University
UNKNOWN
LanZhou University
OTHER
Southern Medical University, China
OTHER
Ankara University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Xiaolong Qi
Director, Hepatic Hemodynamic Lab
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiaolong Qi, MD
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Shenghong Ju, MD
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing 302 Hospital
Beijing, Beijing Municipality, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shunde Hospital, Southern Medical University
Shunde, Guangdong, China
Xingtai People's Hospital
Xingtai, Hebei, China
The First Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhongda Hospital, Medical School of Southeast University
Nanjing, Jiangsu, China
Shandong Provincial Hospital affiliated to Shandong University
Jinan, Shandong, China
Shanghai Public Health Clinical Center, Fudan University
Shanghai, Shanghai Municipality, China
Affiliated Lishui Hospital of Zhejiang University
Lishui, Zhejiang, China
Ankara University School of Medicine
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Sun R, Limkin EJ, Vakalopoulou M, Dercle L, Champiat S, Han SR, Verlingue L, Brandao D, Lancia A, Ammari S, Hollebecque A, Scoazec JY, Marabelle A, Massard C, Soria JC, Robert C, Paragios N, Deutsch E, Ferte C. A radiomics approach to assess tumour-infiltrating CD8 cells and response to anti-PD-1 or anti-PD-L1 immunotherapy: an imaging biomarker, retrospective multicohort study. Lancet Oncol. 2018 Sep;19(9):1180-1191. doi: 10.1016/S1470-2045(18)30413-3. Epub 2018 Aug 14.
Liu 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.
Wang K, Lu X, Zhou H, Gao Y, Zheng J, Tong M, Wu C, Liu C, Huang L, Jiang T, Meng F, Lu Y, Ai H, Xie XY, Yin LP, Liang P, Tian J, Zheng R. Deep learning Radiomics of shear wave elastography significantly improved diagnostic performance for assessing liver fibrosis in chronic hepatitis B: a prospective multicentre study. Gut. 2019 Apr;68(4):729-741. doi: 10.1136/gutjnl-2018-316204. Epub 2018 May 5.
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.
Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available.
Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18.
Lambin P, Leijenaar RTH, Deist TM, Peerlings J, de Jong EEC, van Timmeren J, Sanduleanu S, Larue RTHM, Even AJG, Jochems A, van Wijk Y, Woodruff H, van Soest J, Lustberg T, Roelofs E, van Elmpt W, Dekker A, Mottaghy FM, Wildberger JE, Walsh S. Radiomics: the bridge between medical imaging and personalized medicine. Nat Rev Clin Oncol. 2017 Dec;14(12):749-762. doi: 10.1038/nrclinonc.2017.141. Epub 2017 Oct 4.
Wang C, Huang Y, Liu C, Liu F, Hu X, Kuang X, An W, Liu C, Liu Y, Liu S, He R, Wang H, Qi X. Diagnosis of Clinically Significant Portal Hypertension Using CT- and MRI-based Vascular Model. Radiology. 2023 Apr;307(2):e221648. doi: 10.1148/radiol.221648. Epub 2023 Jan 31.
Liu Y, Tang T, Ormeci N, Huang Y, Wang J, Li X, Li Z, An W, Liu D, Zhang C, Liu C, Liu J, Liu C, Wang G, Mosconi C, Cappelli A, Bruno A, Akcalar S, Celebioglu E, Ustuner E, Bilgic S, Ellik Z, Asiller OO, Li L, Zhang H, Kang N, Xu D, He R, Wang Y, Bu Y, Gu Y, Ju S, Golfieri R, Qi X. Noncontrast-enhanced MRI-based Noninvasive Score for Portal Hypertension (CHESS1802): An International Multicenter Study. J Clin Transl Hepatol. 2021 Dec 28;9(6):818-827. doi: 10.14218/JCTH.2021.00177. Epub 2021 Sep 30.
Liu Y, Ning Z, Ormeci N, An W, Yu Q, Han K, Huang Y, Liu D, Liu F, Li Z, Ding H, Luo H, Zuo C, Liu C, Wang J, Zhang C, Ji J, Wang W, Wang Z, Wang W, Yuan M, Li L, Zhao Z, Wang G, Li M, Liu Q, Lei J, Liu C, Tang T, Akcalar S, Celebioglu E, Ustuner E, Bilgic S, Ellik Z, Asiller OO, Liu Z, Teng G, Chen Y, Hou J, Li X, He X, Dong J, Tian J, Liang P, Ju S, Zhang Y, Qi X. Deep Convolutional Neural Network-Aided Detection of Portal Hypertension in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2998-3007.e5. doi: 10.1016/j.cgh.2020.03.034. Epub 2020 Mar 21.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHESS1802
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.