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

Completed

• Conditions: Chronic Hepatic; Liver Diseases
• Interventions: Procedure: EUS-guided liver biopsy at MDMC

• Registration Number: NCT04055870
• Lead Sponsor: Methodist Health System

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2017-08-21
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-25
• Last Update Posted: 2021-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Undergone EUS-guided liver biopsy at MDMC	EUS-guided liver biopsy at MDMC	Undergone EUS-guided liver biopsy at MDMC

Primary Outcome Measures

Name	Time	Method
Length of core biopsy	9/1/2017 and 9/1/2019
Number of portal tracts	9/1/2017 and 9/1/2019
Diagnostic yield	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.

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States