EUS Share-wave in Patients With Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644055
• Other study ID #: IECED-110520
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: April 15, 2023

Study information

• Verified date: September 2023
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 15, 2023
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Diagnostic Test:
• EUS- share wave of the liver
Evaluation of the right and left hepatic lobe with EUS-guided share wave

Locations

Country	Name	City	State
Ecuador	Ecuadorian Institute of Digestive Diseases	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Ecuatoriano de Enfermedades Digestivas

Country where clinical trial is conducted

Ecuador, 

References & Publications (1)

Robles-Medranda C, Oleas R, Puga-Tejada M, Valero M, Valle RD, Ospina J, Pitanga-Lukashok H. Results of liver and spleen endoscopic ultrasonographic elastography predict portal hypertension secondary to chronic liver disease. Endosc Int Open. 2020 Nov;8(1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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