Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06867731

Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis

The study is being done to collect information on the effectiveness of endosonographic elastography (a technique which uses sound waves) to measure the stiffness of the liver and spleen. Investigators are trying to determine if shear wave elastography is a good way to measure fibrosis instead of biopsy.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

About this study

Study design This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy of Endoscopic ultrasound guided shear wave elastography (EUS-SWE) with liver biopsy for liver fibrosis.

Patients who will undergo a standard-of-care EUS guided liver biopsy (or have clinically obvious liver cirrhosis) will be prospectively enrolled after obtaining informed consent. All enrolled patients will undergo EUS guided liver biopsy, unless they have an obvious diagnosis of cirrhosis. EUS-SWE of the liver and spleen.

In selected patients who have been referred for EUS PPG measurement in addition to EUS liver biopsy, portal pressures will be measured as well and correlated with elastography of the spleen.

The patients will be initially assessed for need for liver biopsy by the gastroenterology/hepatology team as per the current standard of care. Only patients with a clear clinical indication for liver biopsy will be enrolled for the study.

Per current standard of practice at Providence Sacred Heart Medical Center, patients who need liver biopsy are referred to the interventional GI service for the procedure. These patients will be offered participation in the trial prior the endoscopic procedure. This detailed discussion will include participation in the study, background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years (irrespective of sex)
  • Patients determined clinically to have liver cirrhosis needing EUS for other reasons
  • Patients determined clinically to be candidates for EUS guided liver biopsy
  • Elevated liver enzymes without obvious etiology
  • Clinical concern for cirrhosis requiring histological confirmation
  • Patients with known cirrhosis without diagnostic dilemma
  • Ability to provide informed consent and willing to participate

Exclusion criteria

  • Surgically altered foregut anatomy which precludes safe endoscopic liver biopsy
  • Coagulopathy with INR greater than 1.6 in patients on anticoagulant therapy
  • Thrombocytopenia with platelet count less than 50,000/mL
  • Pregnancy (positive urine pregnancy test in females of childbearing age)

Treatment and study plan

Endosonographic Elastography

Procedure

The patient will undergo a standard-of-care endoscopic ultrasound with liver biopsy. At the time, elastography of the liver and spleen will be performed while using the echoendoscope. Different degrees of pressure will be applied while performing elastography of the left and right lobes of the liver as well as the spleen. The E values and VsN values will be recorded and then compared to liver histology.

Endosonographic shear wave elastography

Diagnostic Test

The patient will undergo an upper endoscopic ultrasound procedure. During this procedure, the patient will be put to sleep and a trained endosonographer physician will insert an echo-endoscope through the mouth and guide it down to the stomach and the duodenum. This endoscope is equipped with technology that uses sound waves to assess the stiffness of the liver and spleen. For research purposes, the doctor will also press on these organs in order to take the additional measurements.

Primary outcomes

  1. Degree of fibrosis

    Time frame: Enrollment to 4 weeks

    Assessment of shear wave elastography as a surrogate for histological grade of liver fibrosis

Secondary outcomes

  1. Comparative lobar pressure

    Time frame: Enrollment to 4 weeks

    Compare elastography values with standard or increased pressure

  2. Spleen elasticity

    Time frame: Enrollment to 4 weeks

    Correlation of splenic elastography with portal pressures

Sponsors and collaborators

Lead sponsor

Providence Medical Research Center

Other

Collaborators

  • Fujifilm

Registry information

Official study title

Endosonographic Shear Wave Elastography to Assess Liver Fibrosis

Acronym: EUS SWE liver

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 10, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.