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

NCT ID: NCT04055870

Last Updated: 2021-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-21

Study Completion Date

2020-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatic Liver Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Undergone EUS-guided liver biopsy at MDMC

Undergone EUS-guided liver biopsy at MDMC

EUS-guided liver biopsy at MDMC

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Prashant Kedia, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

045.GID.2017.D

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.