Clinical trial NCT06867731: Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis
Official title: Endosonographic Shear Wave Elastography to Assess Liver Fibrosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Liver Fibrosis
Cirrhosis
Keywords: Liver Fibrosis
Elastography
Liver Biopsy
Shear Wave Elastography
Endosonographic Shear Wave Elastography
Lead sponsor: Providence Medical Research Center
Sponsor class: OTHER
Collaborators: name: Fujifilm
First posted: 2025-03-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Degree of fibrosis
timeFrame: Enrollment to 4 weeks
Secondary outcomes:
measure: Comparative lobar pressure
timeFrame: Enrollment to 4 weeks
measure: Spleen elasticity
timeFrame: Enrollment to 4 weeks
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center
state: Washington
Study officials:
affiliation: Providence Sacred Heart Medical Center
name: Divyanshoo R Kohli, MD FACG FASGE
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.