NCT04644055

EUS Share-wave in Patients With Liver Cirrhosis

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: Instituto Ecuatoriano de Enfermedades Digestivas · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	EUS- share wave of the liver	Evaluation of the right and left hepatic lobe with EUS-guided share wave

Timeline

• Start date: 2020-03-01
• Primary completion: 2022-06-15
• Completion: 2023-04-15
• First posted: 2020-11-25
• Last updated: 2023-09-28

Locations

1 site across 1 country: Ecuador