EUS Share-wave in Patients With Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Observational

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.
    

Intervention name(s): EUS- share wave of the liver
Intervention type(s): Diagnostic Test
Intervention description(s): Evaluation of the right and left hepatic lobe with EUS-guided share wave
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Performed at Instituto Ecuatoriano de Enfermedades Digestivas (IECED), an academic tertiary
        center in Guayaquil, Ecuador. Patients will be invited to participate during outpatient
        clinic visits.

        All consecutive participants need to be ≥18 years old and has a history of chronic liver
        disease with histological proven liver cirrhosis. Control patients will be patients without
        history of chronic liver disease and will be included following a transient elastography
        test within normal limits.
      
Biospecimen description: 
      EUS-guided liver biopsy
    
Keywords: liver cirrhosis; fibrosis; endoscopic ultrasonography; elasticity imaging, tissue