Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis

NCT06867731 | Enrolling By Invitation FDA Device

• 1 other identifier: 2024000651
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Fibrosis; Cirrhosis

Keywords

Liver Fibrosis; Elastography; Liver Biopsy; Shear Wave Elastography; Endosonographic Shear Wave Elastography

Outcome Measures

Primary Outcomes (1)

• Degree of fibrosis

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

  Enrollment to 4 weeks

Secondary Outcomes (2)

• Comparative lobar pressure

  Enrollment to 4 weeks

• Spleen elasticity

  Enrollment to 4 weeks

Study Arms (1)

Elastography

Diagnostic test: Endosonographic shear wave elastography

Procedure: Endosonographic Elastography; Diagnostic Test: Endosonographic shear wave elastography

Interventions

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.

Elastography

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.

Elastography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing standard-of-care upper endoscopic ultrasound for liver biopsy or for other interventions in patients with known cirrhosis

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Providence Medical Research Center: lead
• Fujifilm: collaborator

Study Sites (1)

Providence Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• Kohli DR, Mettman D, Andraws N, Haer E, Porter J, Ulusurac O, Ullery S, Desai M, Siddiqui MS, Sharma P. Comparative accuracy of endosonographic shear wave elastography and transcutaneous liver stiffness measurement: a pilot study. Gastrointest Endosc. 2023 Jan;97(1):35-41.e1. doi: 10.1016/j.gie.2022.08.035. Epub 2022 Aug 29.

  PMID: 36049537 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Divyanshoo R Kohli, MD FACG FASGE

  Providence Sacred Heart Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: March 10, 2025
• Study Start: January 30, 2025
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)