EUS Share-wave in Patients With Liver Cirrhosis

NCT04644055 | Completed DMC

• 1 other identifier: IECED-110520
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Keywords

liver cirrhosis; fibrosis; endoscopic ultrasonography; elasticity imaging, tissue

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Chronic liver disease with liver cirrhosis

Evaluation of the right and left hepatic lobe with EUS-guided share wave evaluation. All patients with chronic liver disease will have a transient elastography evaluation, EUS- elastography of the liver and an EUS-guided liver biopsy.

Diagnostic Test: EUS- share wave of the liver

Control patients

Patients without history of chronic liver disease after clinical and transient elastography evaluation will be submitted for EUS-guided share wave evaluation of the liver. Patients were originally undergoing EUS evaluation for evaluation of suspected subepithelial lesions.

Diagnostic Test: EUS- share wave of the liver

Interventions

EUS- share wave of the liver DIAGNOSTIC_TEST

Evaluation of the right and left hepatic lobe with EUS-guided share wave

Chronic liver disease with liver cirrhosis; Control patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• History of uncontrolled coagulopathy
• Contraindications to EUS-guided liver biopsy
• Pregnancy or nursing
• History of hepatocellular carcinoma
• Patients with equivocal transient elastography results

Sponsors & Collaborators

• Instituto Ecuatoriano de Enfermedades Digestivas: lead

Study Sites (1)

Ecuadorian Institute of Digestive Diseases

Guayaquil, Guayas, 090505, Ecuador

Location

Related 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(11):E1623-E1632. doi: 10.1055/a-1233-1934. Epub 2020 Oct 22.

  PMID: 33140018 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

EUS-guided liver biopsy

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carlos Robles-Medranda, MD FASGE

  Ecuadorian Institute of Digestive Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: March 1, 2020
• Primary Completion: June 15, 2022
• Study Completion: April 15, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

EC (1)