NCT03138915

Brief Summary

This is a prospective, multi-center diagnostic trial conducted at 5 high-volume liver centers in China designed to determine the diagnostic performance of radiomics-based hepatic venous pressure gradient (rHVPG) (investigational technology) by CT angiography (CTA) for noninvasive assessment of the clinically significant portal hypertension (CSPH) in patients with cirrhosis. Direct hepatic venous pressure gradient (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, which is defined as HVPG≥10 mmHg.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

May 18, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2017

Completed
Last Updated

January 8, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

April 29, 2017

Last Update Submit

January 4, 2019

Conditions

Hypertension, Portal

Keywords

clinically significant portal hypertensionhepatic venous pressure gradientradiomics

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy of rHVPG

    Diagnostic accuracy of rHVPG to determine presence or absence of a CSPH when compared to HVPG as the reference standard (HVPG≥10mmHg)

    1 day

Secondary Outcomes (2)

  • Diagnostic Performance of rHVPG

    1 day

  • rHVPG Numerical Correlation

    1 day

Study Arms (1)

Single arm study

EXPERIMENTAL

Patients will receive CTA, HVPG measurement, and rHVPG per protocol. Intervention: Procedure: HVPG measurement

Procedure: HVPG measurementProcedure: CTA

Interventions

HVPG measurementPROCEDURE

HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.

Single arm study
CTAPROCEDURE

Radiomic features were extracted from CTA images.

Single arm study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Patients providing written informed consent
  • Patients with cirrhosis and scheduled to undergo clinically-indicated invasive HVPG measurement by means of catheterization of a hepatic vein with a balloon catheter
  • Has undergone \> 64 multi-detector row CT within 14 days prior to hepatic vein catheterization
  • No hepatic-portal vein interventional therapy between the CT and hepatic vein catheterization

You may not qualify if:

  • Prior transjugular intrahepatic portosystem stent-shunt surgery
  • Prior devascularization operation
  • Has received a liver transplant
  • Patients with known anaphylactic allergy to iodinated contrast
  • Pregnancy or unknown pregnancy status
  • Patient requires an emergent procedure
  • Any active, serious, life-threatening disease
  • Inability to adhere to study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

302 Hospital of PLA

Beijing, Beijing Municipality, China

Location

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Location

Beijing Youan Hospital

Beijing, Beijing Municipality, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Location

Xingtai People's Hospital

Xingtai, Hebei, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Related Publications (6)

  • 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: 26579733BACKGROUND

  • 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: 27786365BACKGROUND

  • 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: 26047908BACKGROUND

  • 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: 30268833RESULT

  • 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: 36719293DERIVED

  • 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: 32205218DERIVED

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Study Officials

  • Xiaolong Qi, M.D

    Nanfang Hospital, Southern Medical University

    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
M.D.

Study Record Dates

First Submitted

April 29, 2017

First Posted

May 3, 2017

Study Start

May 18, 2017

Primary Completion

October 8, 2017

Study Completion

October 8, 2017

Last Updated

January 8, 2019

Record last verified: 2019-01

Locations

CN(6)