Endoscopic Ultrasound vs Percutaneous Route for Liver Biopsy

February 22, 2022 updated by: AdventHealth

Randomized Trial Comparing Endoscopic Ultrasound-guided Liver Biopsy vs. Percutaneous Liver Biopsy

This study is to evaluate and directly compare the technical success, tissue quality, diagnostic efficacy and safety profile of Percutaneous and Endoscopic Ultrasound-guided Liver Biopsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.1 Since it was first performed in 1883, percutaneous (PC) liver biopsy has become routine practice and is usually performed under the guidance of real-time imaging using transabdominal ultrasound (US) or computed tomography (CT).1,2 However, in recent times, liver biopsy has been increasingly performed via transgastric or transduodenal routes under endoscopic ultrasound (EUS) guidance. The perceived advantages of performing EUS-LB compared to PC-LB are the ability to simultaneously assess other organs such as common bile duct and pancreas, access to both left and right lobes of the liver and the routine use of conscious sedation during EUS procedures.3 Although single arm cohort studies and retrospective comparative studies assessing the technical success, tissue quality and safety of these different liver biopsy modalities exist, currently there are no randomized trials comparing PC and EUS-guided LB.4-7

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Center for Interventional Endoscopy

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:

  1. All patients referred for liver biopsy for any reason
  2. Informed consent obtained from the patient
  3. ≥ 18 years old
  4. Able to undergo conscious sedation for EUS procedure

Exclusion Criteria:

  1. <18 years old
  2. Unable to obtain informed consent from the patient
  3. Medically unfit for sedation
  4. Pregnant patients
  5. Presence of a mass lesion in the liver requiring biopsy visualized on cross-sectional imaging
  6. Irreversible coagulopathy as determined by platelet count < 50,000 mm3 or International Normalized Ratio (INR) > 1.5
  7. Unable to stop anticoagulation or anti-platelet therapy for 5 days prior to the procedure
  8. Hemophilia
  9. Presence of an alternative etiology for elevated liver tests seen during liver biopsy, e.g. choledocholithiasis discovered during EUS examination

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Percutaneous Biopsy

The subject would undergo the standard of care procedure for a percutaneous biopsy of the liver.

All percutaneous biopsies will be performed after administration of local anesthetic. No pre-procedure antibiotics will be administered. Subcostal or subxyphoid area will be cleaned and draped in the standard manner. 2% lidocaine solution will be injected subcutaneously using a 25-gauge needle and then administered into the subcutaneous tissue up to the liver capsule. A 16-gauge biopsy needle is inserted into the liver parenchyma under US or CT-guidance, with the location of needle placement left to the discretion of the performing radiologist. One or two core biopsy samples will be obtained. All procured specimens will be placed in a single specimen container of 10% formalin for tissue processing. When biopsy samples have been obtained, the patient will be taken to the recovery area for post-procedure monitoring.
Diagnostic test: biopsy
Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.
ACTIVE_COMPARATOR: Endoscopic-guided Ultrasound Biopsy

The subject would undergo the standard of care procedure for an endoscopic-guided biopsy of the liver.

The left lobe of the liver is identified from the gastric lumen, EUS-guided fine needle biopsy (FNB) will be performed using a 19-gauge FNB needle, with the choice of needle type at the discretion of the performing endoscopist. Stylet will only be used to puncture the liver at the time of the first pass and then subsequently removed. No suction will be used. Fanning technique will not be used. A total of 10 to-and-fro needle movements will be performed during each pass. A total of two passes will be performed.All tissue specimens procured will be placed in a single specimen container of 10% formalin for tissue processing. When two passes are complete under EUS-guidance, the echoendoscope will be withdrawn from the patient and the patient will be taken to the recovery area for post-procedure monitoring.
Diagnostic test: biopsy
Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic adequacy of the tissue sample
Time Frame: 24 hours
The primary outcome of the randomized trial is to compare between EUS-LB and PC-LB, the rate of procurement of diagnostically adequate specimens, defined as the presence of both maximum specimen length ≥ 25mm AND total no. of complete portal tracts ≥ 11.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specimen length
Time Frame: 24 hours
Maximum specimen length in millimeters after formalin fixation will be documented.
24 hours
Portal tracts
Time Frame: 24 hours
The total number of complete portal tracts for each biopsy specimen will be documented.
24 hours
Rates of specimen adequacy
Time Frame: 24 hours
Inadequate specimen - defined as biopsy specimens from which a definitive histological diagnosis cannot be rendered by the pathologist.
24 hours
Cross over
Time Frame: 1 week, 30 days
The rate of crossover to the other treatment arm will be documented
1 week, 30 days
Procedure duration
Time Frame: 24 hours
The total length of time for the procedure will be documented in minutes.
24 hours
Rate of adverse events
Time Frame: 24 hours, 1 week, 30 days
The subject will be asked to report and medical records will be reviewed for any adveerse events related to the procedure.
24 hours, 1 week, 30 days
Procedural costs
Time Frame: 30 days
The subject's account will be reviewed for total costs associated with the procedure.
30 days
Pain scores
Time Frame: 24 hours, 1 week, 30 days
Pain scores measured using the Visual Analog Scale (VAS) on a scale of 0 - 10 with 0 representing no pain and 10 representing the worst pain the subject has ever had; before and after biopsy has been performed.
24 hours, 1 week, 30 days

Collaborators and Investigators

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

Sponsor

AdventHealth

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 (ACTUAL)

July 25, 2019

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

February 11, 2022

Study Registration Dates

First Submitted

June 5, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (ACTUAL)

July 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1438608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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