Liver Cirrhosis
Conditions
Keywords
liver cirrhosis; fibrosis, endoscopic ultrasonography, elasticity imaging, tissue
Brief 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.
Interventions
DIAGNOSTIC_TESTEUS- share wave of the liver
Evaluation of the right and left hepatic lobe with EUS-guided share wave
Sponsors
Instituto Ecuatoriano de Enfermedades Digestivas
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of EUS-share of the liver | 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 | 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. |
Countries
Ecuador
Outcome results
None listed