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

NCT03766880 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2019-08-28

No results posted yet for this study

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

Interventions

PROCEDURE

Transjugular HVPG measurement

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

PROCEDURE

MR imaging

MR images for the post-processing analysis

Sponsors & Collaborators

  • Zhongda Hospital

    collaborator OTHER

  • Beijing 302 Hospital

    collaborator OTHER

  • Affiliated Lishui Hospital of Zhejiang University

    collaborator UNKNOWN

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Xingtai People's Hospital

    collaborator OTHER

  • The First Hospital of Zhengzhou University

    collaborator UNKNOWN

  • Shanghai Public Health Clinical Center, Fudan University

    collaborator UNKNOWN

  • LanZhou University

    collaborator OTHER

  • Southern Medical University, China

    collaborator OTHER

  • Ankara University

    collaborator OTHER

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • Xiaolong Qi, MD · Nanfang Hospital, Southern Medical University

  • Shenghong Ju, MD · Zhongda Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-04
Primary Completion
2019-04-30
Completion
2019-04-30

Countries

  • China
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03766880 on ClinicalTrials.gov