Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Zhongda Hospital | OTHER |
| Beijing 302 Hospital | OTHER |
| Affiliated Lishui Hospital of Zhejiang University | UNKNOWN |
| Shandong Provincial Hospital |
Not provided
Not provided
Not provided
Not provided
Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is invasive and therefore not suitable for routine clinical practice.
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.
Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is invasive and therefore not suitable for routine clinical practice.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Experimental | Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transjugular HVPG measurement | Procedure | By means of catheterization of a hepatic vein with a balloon catheter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Performance of MR-based Models | Accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MR-based models for noninvasive detection of CSPH when compared to HVPG as the reference standard. | 1 day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaolong Qi, MD | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Shenghong Ju, MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing 302 Hospital | Beijing | Beijing Municipality | China | |||
| The First Hospital of Lanzhou University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30215362 | Background | 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. | |
| 30120041 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
Not provided
Not provided
| OTHER_GOV |
| Xingtai People's Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Shanghai Public Health Clinical Center, Fudan University | UNKNOWN |
| LanZhou University | OTHER |
| Southern Medical University, China | OTHER |
| Ankara University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| MR imaging | Procedure | MR images for the post-processing analysis |
|
| 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) |
| 30268833 | Background | 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. |
| 29730602 | Background | 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. |
| 26047908 | Background | 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. |
| 27786365 | Background | 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. |
| 26579733 | Background | 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. |
| 28975929 | Background | 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. |
| 36719293 | Derived | 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. |
| 34966645 | Derived | 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. |
| 32205218 | Derived | 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. |