Comparison of EUS-Guided Liver Biopsy With Percutaneous Liver Biopsy

April 12, 2022 updated by: Marvin Ryou, Brigham and Women's Hospital

Comparison of Pain Scores Between Endoscopic Ultrasound (EUS)-Guided Liver Biopsy and Percutaneous Liver Biopsy

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Percutaneous liver biopsy
Participants will undergo percutaneous liver biopsy per standard protocol.
Experimental: EUS-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.
Procedure: Endoscopic ultrasound-guided liver biopsy
Participants will undergo endoscopic ultrasound per standard technique, with liver biopsy performed at that time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Pain Scores on the Universal Pain Assessment Tool (UPAT)
Time Frame: 48 hours
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Medication Requirements
Time Frame: 48 hours
Use of any analgesics/narcotics
48 hours
Histologic Yield
Time Frame: 1 week
Number of portal triads on histology
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 19, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20162017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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