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Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Assessment of Spleen Stiffness Using VCTE by FibroScan.

NCT03778411 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 298

Last updated 2024-04-19

No results posted yet for this study

Summary

Hypothesis: The severity of portal hypertension in compensated advanced chronic liver disease (cACLD) can be assessed using vibration controlled transient elastography (VCTE) via the FibroScan® 502 Touch by measuring SS (splenic stiffness) Specific Aims: SS by VCTE will be measured in this single center clinical study comprising of 200 patients with cACLD (defined by LSM ≥10 kilopascals (kPa) according to the Baveno VI recommendations) who have not had a liver transplant and 100 subjects who are post-liver transplant. The association between baseline SS values will be examined in relation to the manifestations of portal hypertension such as esophageal or gastric varices.

Specific Aim: To examine the relationship between SS and the presence of esophageal and gastric varices in patients with compensated advanced chronic liver disease (cACLD).

Proposed Study Design: This is a cross sectional study that evaluates the relationship between SS by VCTE in patients with cACLD and manifestations of portal hypertension.

Conditions

  • Advanced Chronic Liver Disease, NASH

Interventions

DEVICE

VCTE with splenic stiffness measurement

Subjects will undergo vibration controlled transient elastography to measure liver stiffness (LSM) liver steatosis via controlled attenuation parameter (CAP) and splenic stiffness

Sponsors & Collaborators

  • Echosens

    collaborator INDUSTRY

  • Indiana University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-03-03
Completion
2023-03-03
FDA Device
Yes

Countries

  • United States

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 NCT03778411 on ClinicalTrials.gov