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

Completed · Not applicable

Conditions studied: Chronic Liver Disease

In brief

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.

Key facts

Study ID

NCT04751045

Run by

University of Missouri-Columbia

People needed

78

Starts

2020-10-25

Expected to finish

2021-10-01

Last updated by the study team

2021-12-09

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• all patients ≥ 18 years of age
• subjects undergoing a liver biopsy for focal/diffuse abnormalities of the liver
• parenchymal disease or chronically elevated liver function tests
• for assessing degree of fibrosis in chronic liver diseases
• or any indication deemed as necessary per the hepatologist/physician

You may not qualify if…

• Age <18
• Coagulopathy (INR of ≥1.5 and/or platelet count ≤ 50,000)
• Use of anticoagulants and/or blood thinners within 24 hours before the planned procedure
• Liver lesions such as hemangioma, echinococcal cyst or vascular tumors,
• Pregnancy,
• Uncooperative patients
• Any other condition or abnormalities that, in the opinion of the referring hepatologist or the advanced endoscopist, may compromise the safety of the patient or interfere with the patient participating in or completing the study.

Where it is running

• University of Missouri Hospital — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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