Radiomics Signature of Hepatic Venous Pressure Gradient (rHVPG) With CT Angiography (CHESS1701)

NCT ID: NCT03138915

Last Updated: 2019-01-08

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-18

Study Completion Date

2017-10-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, multi-center diagnostic trial conducted at 5 high-volume liver centers (302 Hospital of PLA; Beijing Shijitan Hospital; The Third Xiangya Hospital of Central South University; Beijing Youan Hospital; Xingtai People's Hospital) 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension, Portal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single arm study

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

Group Type EXPERIMENTAL

HVPG measurement

Intervention Type PROCEDURE

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

CTA

Intervention Type PROCEDURE

Radiomic features were extracted from CTA images.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HVPG measurement

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

Intervention Type PROCEDURE

CTA

Radiomic features were extracted from CTA images.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beijing 302 Hospital

OTHER

Sponsor Role collaborator

Beijing Shijitan Hospital, Capital Medical University

OTHER

Sponsor Role collaborator

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Beijing YouAn Hospital

OTHER

Sponsor Role collaborator

Xingtai People's Hospital

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiaolong Qi

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xiaolong Qi, M.D

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

302 Hospital of PLA

Beijing, Beijing Municipality, China

Site Status

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Youan Hospital

Beijing, Beijing Municipality, China

Site Status

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status

Xingtai People's Hospital

Xingtai, Hebei, China

Site Status

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26579733 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27786365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26047908 (View on PubMed)

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.

Reference Type RESULT
PMID: 30268833 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36719293 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32205218 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHESS1701

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MRI in Portal Hypertension
NCT01756859 UNKNOWN