Comparison of EUS-Guided Liver Biopsy With Percutaneous Liver Biopsy

Not Applicable

Withdrawn

• Conditions: Fibrosis
• Interventions: Procedure: Percutaneous liver biopsy; Procedure: Endoscopic ultrasound-guided liver biopsy

• Registration Number: NCT02947516
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

There are several ways to perform liver biopsies, including the percutaneous route (historical gold standard) and via endoscopic ultrasound (EUS) guidance. The primary aim of this study is to prospectively compare patients undergoing EUS-guided liver biopsies to patients undergoing percutaneous biopsy. The investigators hypothesize that (1) patients who are randomized to undergo EUS-guided liver biopsy will rate themselves as having less pain in the 48 hours following the procedure, and (2) will have comparable histologic yield to a 2:1 matched cohort of patients undergoing percutaneous liver biopsies.

Detailed Description

Currently, liver biopsy is the gold standard for determining the index of liver fibrosis in a patient with chronic liver disease, and whether the patient has progressed to cirrhosis. These biopsies are predominantly performed percutaneously. However, there are several complications related to liver biopsy, the most common of which are pain and bleeding.

There has been significant movement over the past several years to assess the utility of alternative techniques and approaches for the evaluation of liver disease. Endoscopic ultrasound (EUS) is a well-established technique for diagnostic and therapeutic evaluation of gastrointestinal and pancreaticobiliary disorders. EUS-guided liver biopsy (EUS-LB) has shown to be technically simple, safe, and provides adequate diagnostic yield for evaluation of liver disease in both children and adults. There are several advantages to EUS-LB. First, it would theoretically be less painful than the percutaneous approach, as it does not require skin puncture and also offers the comfort of sedation and analgesia. It also eliminates the need for breath hold. Furthermore, it is an image-guided approach which allows visualization and avoidance of blood vessels even 1 mm in size. Additionally, it provides an access area to a much wider segment of liver parenchyma as the entire left lobe, and the majority of the right lobe can be evaluated for possible needle puncture sites from the stomach and duodenal bulb, respectively. In addition to obtaining tissue, EUS-LB also offers the benefit of evaluating the biliary tree, gallbladder, pancreas, lymph nodes, and vascular anatomy for a more comprehensive evaluation in the same setting. Finally, in patients ultimately found to have biopsy-proven cirrhosis, it simultaneously provides the necessary variceal screening which would otherwise require an additional procedure.

The aim of this study is to prospectively perform EUS-guided liver biopsies in patients who are otherwise candidates for percutaneous biopsy. We hypothesize that (1) patients who are randomized to undergo EUS-guided liver biopsy will rate themselves as having less pain in the 48 hours following the procedure and (2) will have comparable histologic yield to a 2:1 matched cohort of patients undergoing percutaneous transjugular liver biopsies.

Study Timeline

• Study First Submitted: 2016-10-25
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Study Start: 2017-01
• Primary Completion: 2018-06
• Study Completion: 2018-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age 18 years and older
• Eligibility for receiving conscious sedation or monitored anesthesia care
• Abnormal liver function tests with comprehensive previous evaluation (including serologic testing and cross-sectional imaging) leading to an appropriate decision to proceed with liver biopsy and/or portal pressure measurements.

Exclusion Criteria

• Suspected or known malignant liver disease
• Severe thrombocytopenia (platelets <50,000/microL)
• Severe coagulopathy (international normalized ratio [INR] > 1.7 or other known coagulopathy)
• Use of antiplatelet agents within 7 days of the procedure
• Inability to provide informed consent
• Pregnancy or suspected pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous liver biopsy	Percutaneous liver biopsy	Participants will be referred for liver biopsy by their hepatologist/gastroenterologist. The intervention is that these participants will undergo a percutaneous liver biopsy per standard protocol.
EUS-guided liver biopsy	Endoscopic ultrasound-guided liver biopsy	Participants will be referred for liver biopsy by their hepatologist/gastroenterologist. The intervention is that these participants will undergo an endoscopic ultrasound procedure per standard protocol. The liver will be identified, and Color Doppler imaging prior to needle puncture will confirm lack of significant vascular structures within the needle path. Liver biopsies using up to 1-2 passes from the left hepatic lobe using a transgastric approach and up to 1-2 passes from the right hepatic lobe using a transduodenal bulb approach will be performed. The participant will be observed in the recovery unit for up to 60 minutes after the EUS-LB, and discharged if no pain or signs of complication.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Pain Scores on the Universal Pain Assessment Tool (UPAT)	48 hours

Secondary Outcome Measures

Name	Time	Method
Pain Medication Requirements	48 hours	Use of any analgesics/narcotics
Histologic Yield	1 week	Number of portal triads on histology