NCT03277651

Brief Summary

This study is to establish a noninvasive diagnostic platform based on hemodynamic information for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

2.2 years

First QC Date

September 4, 2017

Last Update Submit

January 9, 2018

Conditions

Liver FibrosisCirrhosisPortal Hypertension

Keywords

noninvasiveHemodynamics

Outcome Measures

Primary Outcomes (5)

  • Sensitivity

    Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

    baseline

  • Specificity

    Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

    baseline

  • Positive predictive value (PPV)

    Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

    baseline

  • Negative predictive value (NPV)

    Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

    baseline

  • Area under ROC curve (AUROC)

    Diagnostic power of the hemodynamics based noninvasive platform for liver fibrosis or portal hypertension

    baseline

Study Arms (2)

liver fibrosis

liver biopsy proved

Diagnostic Test: hemodynamics tests

portal hypertension

hepatic venous pressure gradient (HVPG) proved

Diagnostic Test: hemodynamics tests

Interventions

hemodynamics testsDIAGNOSTIC_TEST

Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound

liver fibrosisportal hypertension

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Inpatients who undergo liver biopsy or hepatic venous pressure gradient test in Zhongshan hospital Fudan University

You may qualify if:

  • Inpatients who undergo liver biopsy or hepatic venous pressure gradient test

You may not qualify if:

  • decompensated liver diseases (including ascites, variceal bleeding or hepatic encephalopathy);
  • alpha-fetoprotein \>100 ng/ml or serum creatinine \>1.5 Ă— upper limit of normal (ULN);
  • any malignant tumor;
  • any complications of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases;
  • severe neurological or psychological disease;
  • pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

  • Zheng L, Shi N, Li P, Ge H, Tu C, Qu Y, Wang Y, Lin Y, Chen S, Sun D, Weng C, Wu S, Jiang W. Development and validation of machine learning models to predict esophagogastric variceal rebleeding risk in HBV-related cirrhosis after endoscopic treatment: a prospective multicenter study. EClinicalMedicine. 2025 Aug 20;87:103436. doi: 10.1016/j.eclinm.2025.103436. eCollection 2025 Sep.

    PMID: 40896458DERIVED

MeSH Terms

Conditions

Liver CirrhosisFibrosisHypertension, Portal

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wei Jiang

    Fudan University

    STUDY CHAIR

Central Study Contacts

Shengdi Wu

CONTACT

0086-021-64041990wu.shengdi@zs-hospital.sh.cn

Wei Jiang

CONTACT

0086-021-64041990jiang.wei@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 11, 2017

Study Start

October 9, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

January 10, 2018

Record last verified: 2018-01

Locations

CN(1)