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

NCT03778411 | Completed DMC FDA Device

• 1 other identifier: 1804223843
• Study Type: observational
• Target: 298
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Risks of decompensation

  The relationship between splenic stiffness (SS) and the presence of esophageal and gastric varices in patients with compensated advanced chronic liver disease (cACLD) will be measured with VCTE by the CAP score. CAP is measured in dB/M, with a score range from 100-400. A score of 225 or less is considered to indicate a normal amount of fat in the liver. As the score increases, the amount of steatosis (fat) in the liver is also thought to be elevated.

  Two years

Secondary Outcomes (1)

• Risks of decomposition

  Two years

Study Arms (2)

cACLD

200 people with compensated advanced chronic liver disease who have not undergone liver transplant

Device: VCTE with splenic stiffness measurement

cACLD-post transplant

100 people with compensated advanced chronic liver disease who have previously undergone liver transplant

Device: VCTE with splenic stiffness measurement

Interventions

VCTE with splenic stiffness measurement DEVICE

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

cACLD; cACLD-post transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

200 patients with compensated advanced chronic liver disease (defined by LSM ≥10 kilopascals (kPa) who have not had a liver transplant and 100 subjects with compensated advanced chronic liver disease who are post-liver transplant.

You may qualify if:

• Adults aged 18 years or older
• Ability to provide informed consent
• Previous Fibroscan with LSM ≥10 kilopascals (kPa)

You may not qualify if:

• Inability or refusal to provide informed consent
• Fasting for less than three hours prior to the scan
• Subject is a pregnant or lactating female
• Subject with current, significant alcohol consumption
• Subject is unable to reliably quantify alcohol consumption based upon local study physician judgment
• Patients with a pacemaker or defibrillator
• Acute hepatitis defined as AST/ALT \> 500 U/L

Sponsors & Collaborators

• Indiana University: lead
• Echosens: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: December 19, 2018
• Study Start: December 1, 2020
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)