EUS Share-wave in Patients With Liver Cirrhosis

Study Overview
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Brief Summary
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Patients with chronic liver disease may develop progressive hepatic fibrosis. Liver cirrhosis should be detected at the early stages in order to avoid the complications related to these two conditions. The diagnostic work-up of patients with chronic liver disease includes less-invasive diagnostic methods such as abdominal ultrasonography, transient elastography, upper endoscopy; and more invasive procedures, mainly liver biopsy and portal pressure gradient measurement, both with associated risks. Endoscopic ultrasound offers a benefit of including all diagnostic work-up in a single procedure. The investigators previously demonstrated that EUS-elastography of the liver and spleen is reliable marker for predicting liver cirrhosis. Recently, a quantitative evaluation of fibrosis using share wave elastography was introduced, mainly for the pancreatic tumor fibrosis measurement (2). Elastography measures the elasticity of tissues (hardness); whereas share wave measures the tissue elasticity as the elastic modulus by measuring the share wave velocity. Share wave measurement will be performed with the Arietta 850 Endoscopic ultrasound console using a linear ultrasound video gastroscope EUS-J10 (Pentax Medical, Hoya Corp, Japan). The investigators proposed the EUS-share wave of the liver as a reliable diagnostic marker in patients with liver cirrhosis.

Detailed Description
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A non-blinded, prospective trial. Primary disease condition: liver cirrhosis Keywords: Liver Cirrhosis; Fibrosis; Endoscopic Ultrasonography; Elasticity Imaging, Tissue. Study Design: Observational study model: a non-blinded, non-randomized, prospective trial Time perspective: prospective Enrollment type: actual Number of subjects: 16 participants Number of groups/cohorts: 2 cohorts Target follow-up duration: 6 months Based on the proportion of patients with the liver strain histogram (LSH) >87.40 among cirrhosis (87.5%) and control cases (31.0%) described by Robles-Medranda et al. (1), the investigators calculated eight patients per study group with a 5% and 20% of alpha and beta error respectively, with an 80% of power statistic.

Official Title
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Endoscopic Ultrasound Share-wave for the Evaluation of Patients With Chronic Liver Disease

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Diagnostic Test: EUS- share wave of the liver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provided informed written consent Age greater than 18 years of age Confirmed diagnosis of chronic liver disease based on transient elastography Patients with EUS-guided liver biopsy Exclusion Criteria: History of uncontrolled coagulopathy Contraindications to EUS-guided liver biopsy Pregnancy or nursing History of hepatocellular carcinoma Patients with equivocal transient elastography results

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic liver disease with liver cirrhosis<br>Evaluation of the right and left hepatic lobe with EUS-guided share wave evaluation. All patients with chronic liver disease will have a transient elastography evaluation, EUS- elastography of the liver and an EUS-guided liver biopsy. | Diagnostic Test: EUS- share wave of the liver<br>* Evaluation of the right and left hepatic lobe with EUS-guided share wave<br>|
| Control patients<br>Patients without history of chronic liver disease after clinical and transient elastography evaluation will be submitted for EUS-guided share wave evaluation of the liver. Patients were originally undergoing EUS evaluation for evaluation of suspected subepithelial lesions. | Diagnostic Test: EUS- share wave of the liver<br>* Evaluation of the right and left hepatic lobe with EUS-guided share wave<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of EUS-share of the liver | Evaluation of the correlation between transient elastography, EUS-elastography of the liver, EUS-guided liver biopsy and EUS-guided share wave of the liver | 2 months | 
| Diagnostic accuracy of EUS-share wave of the liver | Evaluate the diagnostic accuracy of EUS- share wave of the liver for predicting liver cirrhosis. Receiver operating characteristic curve development with evaluation of the sensitivity, specificity, PPV and NPV of EUS-guided share wave of the liver to predict liver cirrhosis. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cirrhosis; fibrosis, endoscopic ultrasonography, elasticity imaging, tissue