CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 78 enrolled
Drug / intervention
EUS liver biopsyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04751045
NCT04751045N/ACompleted

Comparison and Outcomes of Endoscopic Ultrasound Liver Biopsies Versus Percutaneous Liver Biopsies: A Randomized Clinical Trial

University of Missouri-Columbia·interventional·Posted Feb 11, 2021·Updated Dec 9, 2021

In Brief

A clinical study evaluating EUS liver biopsy for Chronic Liver Disease. Completed, enrolled 78 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 11, 2021
Enrollment StartOct 25, 2020
Primary CompletionOct 1, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.4 years ago

Interventions

EUS liver biopsyprocedure

Endoscopic ultrasound guided liver biopsy