MR-based Models for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)

NCT03766880 | Completed DMC

• 1 other identifier: CHESS1802
• Study Type: interventional
• Target: 175
• Locations: 2 countries
• Sites: 11

Brief Summary

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.

Conditions

Hypertension, Portal

Keywords

clinically significant portal hypertension, hepatic venous pressure gradient, MR imaging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single arm study

EXPERIMENTAL

Participants will receive MR imaging, transjugular HVPG measurement, and analysis per protocol.

Procedure: Transjugular HVPG measurement; Procedure: MR imaging

Interventions

Transjugular HVPG measurement PROCEDURE

By means of catheterization of a hepatic vein with a balloon catheter.

Single arm study

MR imaging PROCEDURE

MR images for the post-processing analysis

Single arm study

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• 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

You may not qualify if:

• A contraindication to MR imaging, in particular pacemakers or implantable defibrillators, cochlear implants, neurosurgical clips, intra-orbital or brain metallic foreign bodies, endo prothesis since less than 4 weeks or osteosynthesis material since less than 6 weeks
• 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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Zhongda Hospital: collaborator
• Beijing 302 Hospital: collaborator
• Affiliated Lishui Hospital of Zhejiang University: collaborator
• Shandong Provincial Hospital: collaborator
• Xingtai People's Hospital: collaborator
• The First Hospital of Zhengzhou University: collaborator
• Shanghai Public Health Clinical Center, Fudan University: collaborator
• LanZhou University: collaborator
• Southern Medical University, China: collaborator
• Ankara University: collaborator

Study Sites (11)

Beijing 302 Hospital

Beijing, Beijing Municipality, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Shunde Hospital, Southern Medical University

Shunde, Guangdong, China

Location

Xingtai People's Hospital

Xingtai, Hebei, China

Location

The First Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Zhongda Hospital, Medical School of Southeast University

Nanjing, Jiangsu, China

Location

Shandong Provincial Hospital affiliated to Shandong University

Jinan, Shandong, China

Location

Shanghai Public Health Clinical Center, Fudan University

Shanghai, Shanghai Municipality, China

Location

Affiliated Lishui Hospital of Zhejiang University

Lishui, Zhejiang, China

Location

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 30215362 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.

  PMID: 30120041 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.

  PMID: 30268833 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.

  PMID: 29730602 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.

  PMID: 26047908 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.

  PMID: 27786365 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.

  PMID: 26579733 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.

  PMID: 28975929 BACKGROUND

• 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.

  PMID: 36719293 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.

  PMID: 34966645 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.

  PMID: 32205218 DERIVED

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Xiaolong Qi, MD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

• Shenghong Ju, MD

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Hepatic Hemodynamic Lab

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 6, 2018
• Study Start: December 4, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

CN (10); TU (1)