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Completed

NCT Number: NCT04055870

Efficacy, Safety, and Adequacy of EUS-guided Liver Biopsy

The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC).

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Key information

Conditions

Chronic Hepatic Digestive System Diseases Liver Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

About this study

The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients undergoing EUS-guided liver biopsy at Methodist Dallas Medical Center (MDMC). This is a clinical quality improvement (CQI) initiative to evaluate outcomes within our institution. The data collected will be used to inform new innovative ways to improve EUS-guided liver biopsy with an ultimate goal of improving the quality of patient care. The clinical outcomes of this patient population have not been previously systematically reviewed in MDMC. Currently, the procedure in not being performed routinely at Methodist Dallas Medical Center (MDMC). However, with new technical and physician expertise, this option is now available at our institution. PI will evaluate the efficacy, safety, and adequacy of EUS-guided liver biopsy in patients requiring histologic examination of their liver at MDMC.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older
  • Undergone EUS-guided liver biopsy at MDMC

Exclusion criteria

  • Below 18 years of age
  • Did not undergo EUS-guided liver biopsy at MDMC

Treatment and study plan

EUS-guided liver biopsy at MDMC

Procedure

Endoscopic ultrasound (EUS) guided liver biopsy sampling is emerging as an alternative to the aforementioned approaches that offers several advantages, including decreased sampling variability and procedure-related complications.

Primary outcomes

  1. Length of core biopsy

    Time frame: 9/1/2017 and 9/1/2019

  2. Number of portal tracts

    Time frame: 9/1/2017 and 9/1/2019

  3. Diagnostic yield

    Time frame: 9/1/2017 and 9/1/2019

    We will define an adequate specimen as one containing ≥11 portal tracts or measuring ≥20 mm cumulative core length.

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 14, 2019
Registry last updated
Jun 28, 2021

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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