Recruiting

Endosonographic Shear Wave Elastography

Sponsor:

Midwest Biomedical Research Foundation

Code:

NCT04533932

Conditions

Liver Cirrhosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Elastography

Study Details

Brief summary:

This is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy and safety of endosonographic real-time Elastography and shear wave Elastography with the current standards of care, i.e. liver biopsy and Vibration-controlled transient elastography (Fibroscan). Subjects who are referred for an endoscopic ultrasound (EUS) guided liver biopsy will be prospectively enrolled to undergo liver biopsy, Elastography and/or Vibration-controlled transient elastography.

Conditions

Liver Cirrhosis

Study ID

NCT04533932

Start date

Sep 8, 2020

Status verified date

Feb, 2021

Completion date

Aug, 2021

Anticipated

Primary completion date

Aug, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients referred for EUS guided liver biopsy
  • Elevated liver enzymes without obvious etiology, thus necessitating liver biopsy or clinical concern for cirrhosis or NASH requiring histological confirmation
  • Ability to provide informed consent and willing to participate

Exclusion Criteria:

  • Clinical evidence of cirrhosis which obviates need for liver biopsy
  • Noninvasive lab testing which confirms presence of cirrhosis
  • 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)
  • Lack of consent

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Elastography

Interventions

Elastography

Endosonographic shear wave elastography

Primary outcome measure

  • Degree of fibrosis [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Divyanshoo R Kohli, MD

8168614700divyanshoo.kohli2@va.gov

Locations

Kansas City VA Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

More Information

Sponsor

Midwest Biomedical Research Foundation

Last update posted

Feb 23, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Midwest Biomedical Research Foundation on 2021-02-23.