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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Chronic Hepatic
• Liver Diseases

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