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NCT04055870 Clinical Trial

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

Liver Diseases Clinical Trial

Official title:
Efficacy, Safety, and Adequacy of EUS-guided Liver Biopsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04055870
Other study ID # 045.GID.2017.D
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 21, 2017
Est. completion date October 30, 2020

Study information
Verified date June 2021
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date October 30, 2020
Est. primary completion date October 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• EUS-guided liver biopsy at MDMC
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.

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Length of core biopsy 9/1/2017 and 9/1/2019
Primary Number of portal tracts 9/1/2017 and 9/1/2019
Primary Diagnostic yield We will define an adequate specimen as one containing =11 portal tracts or measuring =20 mm cumulative core length. 9/1/2017 and 9/1/2019
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