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Completed

NCT Number: NCT04003766

Endoscopic Ultrasound vs Percutaneous Route for 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.

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Key information

Conditions

Liver Biopsy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Interventional Endoscopy

Orlando, Florida, 32803, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Biopsy

Diagnostic Test

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Specimen length

    Time frame: 24 hours

    Maximum specimen length in millimeters after formalin fixation will be documented.

  2. Portal tracts

    Time frame: 24 hours

    The total number of complete portal tracts for each biopsy specimen will be documented.

  3. 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.

  4. Cross over

    Time frame: 1 week, 30 days

    The rate of crossover to the other treatment arm will be documented

  5. Procedure duration

    Time frame: 24 hours

    The total length of time for the procedure will be documented in minutes.

  6. 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.

  7. Procedural costs

    Time frame: 30 days

    The subject's account will be reviewed for total costs associated with the procedure.

  8. 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.

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Jul 1, 2019
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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