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

Hypertension, Portal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03766880
• Other study ID #: CHESS1802
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: August 2019
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal

Intervention

Procedure:
• Transjugular HVPG measurement
By means of catheterization of a hepatic vein with a balloon catheter.
• MR imaging
MR images for the post-processing analysis

Locations

Country	Name	City	State
China	Beijing 302 Hospital	Beijing	Beijing
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Shandong Provincial Hospital affiliated to Shandong University	Jinan	Shandong
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Affiliated Lishui Hospital of Zhejiang University	Lishui	Zhejiang
China	Zhongda Hospital, Medical School of Southeast University	Nanjing	Jiangsu
China	Shanghai Public Health Clinical Center, Fudan University	Shanghai	Shanghai
China	Shunde Hospital, Southern Medical University	Shunde	Guangdong
China	Xingtai People's Hospital	Xingtai	Hebei
China	The First Hospital of Zhengzhou University	Zhengzhou	Henan
Turkey	Ankara University School of Medicine	Ankara

Sponsors (11)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Affiliated Lishui Hospital of Zhejiang University, Ankara University, Beijing 302 Hospital, LanZhou University, Shandong Provincial Hospital, Shanghai Public Health Clinical Center, Fudan University, Shunde Hospital, Southern Medical University, The First Hospital of Zhengzhou University, Xingtai People's Hospital, Zhongda Hospital, Medical School of Southeast University

Countries where clinical trial is conducted

China,  Turkey, 

References & Publications (8)

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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. Erratum in: Hepatology. 2017 Jul;66(1):304. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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, Ferté 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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