NCT04055870

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

3.2 years

First QC Date

August 12, 2019

Last Update Submit

June 25, 2021

Conditions

Chronic HepaticLiver Diseases

Outcome Measures

Primary Outcomes (3)

  • Length of core biopsy

    9/1/2017 and 9/1/2019

  • Number of portal tracts

    9/1/2017 and 9/1/2019

  • 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

Study Arms (1)

Undergone EUS-guided liver biopsy at MDMC

Undergone EUS-guided liver biopsy at MDMC

Procedure: EUS-guided liver biopsy at MDMC

Interventions

EUS-guided liver biopsy at MDMCPROCEDURE

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.

Undergone EUS-guided liver biopsy at MDMC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Age 18 years or older and have undergone EUS-guided liver biopsy at MDMC

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Prashant Kedia, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2019

First Posted

August 14, 2019

Study Start

August 21, 2017

Primary Completion

October 30, 2020

Study Completion

October 30, 2020

Last Updated

June 28, 2021

Record last verified: 2021-06

Locations

US(1)