EUS Share-wave in Patients With Liver Cirrhosis

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.

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Key information

Conditions

Liver Cirrhosis Digestive System Diseases Fibrosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, 090505, Ecuador

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS- share wave of the liver

Diagnostic Test

Evaluation of the right and left hepatic lobe with EUS-guided share wave

Primary outcomes

Correlation of EUS-share of the liver

Time frame: 2 months

Evaluation of the correlation between transient elastography, EUS-elastography of the liver, EUS-guided liver biopsy and EUS-guided share wave of the liver
Diagnostic accuracy of EUS-share wave of the liver

Time frame: 2 months

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.

Sponsors and collaborators

Lead sponsor

Instituto Ecuatoriano de Enfermedades Digestivas

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Nov 25, 2020
Registry last updated: Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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