Clinical trial NCT04644055: EUS Share-wave in Patients With Liver Cirrhosis
Official title: Endoscopic Ultrasound Share-wave for the Evaluation of Patients With Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Keywords: liver cirrhosis; fibrosis
endoscopic ultrasonography
elasticity imaging, tissue
Lead sponsor: Instituto Ecuatoriano de Enfermedades Digestivas
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of EUS-share of the liver
timeFrame: 2 months
measure: Diagnostic accuracy of EUS-share wave of the liver
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Ecuadorian Institute of Digestive Diseases
state: Guayas
Study officials:
affiliation: Ecuadorian Institute of Digestive Diseases
name: Carlos Robles-Medranda, MD FASGE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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(11):E1623-E1632. doi: 10.1055/a-1233-1934. Epub 2020 Oct 22.