NCT04751045

Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies

Completed NA Last updated 9 December 2021

What this trial tests

NA trial testing EUS liver biopsy in Chronic Liver Disease in 78 participants. Completed in 1 October 2021.

Timeline

25 October 2020

Primary endpoint
1 October 2021

1 October 2021

Quick facts

Lead sponsor	University of Missouri-Columbia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	78
Start date	25 October 2020
Primary completion	1 October 2021
Estimated completion	1 October 2021
Sites	1 location across United States

Drugs / interventions tested

• EUS liver biopsy

Conditions studied

• Chronic Liver Disease — all drugs for Chronic Liver Disease →

Sponsor

University of Missouri-Columbia

Who can join

Eligibility, any sex, with Chronic Liver Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Histopathological examination of liver tissue is used to determine the etiology and extent of liver disease. In order for a clinician to make a better-informed decision regarding a patient with liver disease, the liver biopsy specimen has to be adequate and of high quality for pathological interpretation. It is generally agreed that an adequate liver biopsy has to have ≥6-12 intact portal tracts for pathological review and interpretation.(1) Historically, three approaches have been used to obtain a liver biopsy: percutaneous, transjugular (TJ-LB) and laparoscopic approach (LA-LB)- with percutaneous liver biopsy (P-LB) being the most commonly employed. Endoscopic ultrasound-guided liver biopsy (EUS-LB), a newer approach, is now being performed by select skilled endoscopists across the country. EUS-LB is advantageous over existing techniques because it enables visualization and avoidance of vessels that are 1mm in diameter, provides access to both lobes of the liver and theoretically is less painful due to avoiding somatic pain fibers. Further, in patients that are already undergoing esophagogastroduodenoscopy, EUS-LB can be performed simultaneously and spare the patient an additional procedure. Because of the plausibility of reduced pain, number of procedures and possibly complications, EUS-LB may be cost-effective over existing methods. There is limited data evaluating the safety and efficacy of EUS-LB versus percutaneous liver biopsy.

The investigators hope to provide answers in a prospective study comparing between patients, who are already undergoing liver biopsy, randomly assigned to either EUS-LB or P-LB. The investigators will compare outcomes such as pain, bleeding, hospitalization, and tissue diagnosis between the two groups. This will allow us to add to the existing data for the use of EUS-LB. If patients are found to have less adverse events and better outcomes using EUS-LB versus percutaneous-LB this may become the preferred method of diagnosis in this patient population.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. EUS-guided <i>versus</i> percutaneous liver biopsy: A prospective randomized clinical trial.
   Ali AH, Nallapeta NS, Yousaf MN, Petroski GF, et al · · 2023 · cited 17× · PMID 37693114 · DOI 10.1097/eus.0000000000000010
2. Endo-hepatology: Updates for the clinical hepatologist.
   Lee F, Rustagi T, Frederick RT. · · 2023 · cited 4× · PMID 37663555 · DOI 10.1097/cld.0000000000000072