Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy

June 12, 2023 updated by: Suresh Vasan Venkatachalapathy, Nottingham University Hospitals NHS Trust

The goal of this study is to learn about endoscopic ultrasound(EUS) guided liver biopsy and how this compares to traditional methods of obtaining liver biopsy samples, in patients with liver disease.

The main questions it aims to answer are:

  1. is EUS liver biopsy equally as good as other types of techniques
  2. are there any advantages to using the EUS technique to obtain liver biopsies Researchers will compare data from patients who have had a liver biopsy with a traditional technique with those who have undergone EUS-guided biopsy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction:

The rising incidence of liver disease (LD) has led to an increased demand on services for accurate and prompt diagnosis and staging, to facilitate treatments and early interventions. While non-invasive diagnostic tests (e.g. transient elastography, ELF biomarkers) are the standard of care to stratify fibrosis burden, there are still cases that require a liver biopsy (LB) for assessment of fibrosis and aetiology of disease. Traditional methods such as percutaneous LB (PLB) and transjugular LB (TJLB) are well established, however there is a recognised burden on the services, translating to prolonged waiting times and delays in diagnosis. Endoscopic ultrasound-guided liver biopsy (EUS-LB) is emerging as a novel, minimally invasive way of not only securing a tissue sample, but also providing an in-depth assessment of other parameters such as portal pressure gradient (PPG), shearwave measurement (SWM) and varices assessment. The aim of this study was to test the diagnostic adequacy, fibrosis staging, length of stay post procedure and complication rates following the above modalities of Liver biopsy.

Methods:

This is a single centre prospective observational study to assess the diagnostic accuracy of liver biopsy through different modalities. Data will be as collected prospectively from all adult patients patients undergoing any form of LB in a single tertiary hospital for 12 months:September 2022 to September 2023. Information was collected will be on demographics, biopsy indication, length of core, length of stay (LoS), complications and diagnostic yield.

Primary aim: To assess the diagnostic yield of liver biopsy through EUS-LB, Trans-jugular liver biopsy and percutaneous ultrasound guided liver biopsy.

Secondary aim;

  1. Technical success rate,
  2. Length of the cores obtained
  3. Number of portal tracts
  4. Accuracy of Shear wave measurement compared to Liver biopsy
  5. complications rate
  6. Length of stay

Dissemination plan:

the results of the study will be disseminated through presentation at national/ international meetings and publishing in peer reviewed journals.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This is a prospective observation of all consecutive adult patients undergoing Liver biopsy.

Description

Inclusion Criteria:

  • 18 years or older
  • underwent liver biopsy either through EUS, percutaneous or transjugular route

Exclusion Criteria:

- under 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EUS guided liver biopsy
Patients having liver biopsy through endoscopic ultrasound technique
Diagnostic test: liver biopsy - EUS guided
liver biopsy obtained during endoscopic ultrasound
Percutaneous liver biposy
Patients having liver biopsy percutaneously
Diagnostic test: Liver biopsy - percutaneous
liver biopsy obtained using percutaneous ultrasound guided technique
Transjugular liver biopsy
Patients having liver biopsy via a transjugular route
Diagnostic test: Liver biopsy - transjugular
liver biopsy obtained using an interventional transjugular approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of patients with adquate tissue to make accurate diagnosis with different modalities of Liver biopsy
Time Frame: 1 year
patient in whom a diagnosis has been reached or supported by histological results
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: 1 year
length of stay of patients undergoing different Liver biopsy modalities
1 year
Complication rate with different modalities
Time Frame: 30 days
complication rate of different modalities of liver biopsy
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nottingham University Hospitals NHS Trust

Investigators

  • Principal Investigator: Suresh Vasan Suresh Vasan, Nottingham University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

September 30, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

June 12, 2023

First Submitted That Met QC Criteria

June 12, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 12, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-577C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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