EUS Share-wave in Patients With Liver Cirrhosis

Instituto Ecuatoriano de Enfermedades Digestivas

Status: Completed

Conditions: Liver Cirrhosis

Treatments: Diagnostic Test: EUS- share wave of the liver

Study type: Observational

Funder types: Other

Identifiers

NCT04644055

IECED-110520

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

59 participants in 2 patient groups

Chronic liver disease with liver cirrhosis

Description:

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.

Treatment:

Diagnostic Test: EUS- share wave of the liver

Control patients

Description:

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.

Treatment:

Diagnostic Test: EUS- share wave of the liver