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

NHS Trust

Status: Enrolling

Conditions: Liver Fibrosis; Liver Diseases

Treatments: Diagnostic Test: Liver biopsy - transjugular; Diagnostic Test: liver biopsy - EUS guided; Diagnostic Test: Liver biopsy - percutaneous

Study type: Observational

Funder types: Other

Identifiers

NCT05912179

22-577C

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• under 18 years of age

Trial design

200 participants in 3 patient groups

EUS guided liver biopsy

Description:

Patients having liver biopsy through endoscopic ultrasound technique

Treatment:

Diagnostic Test: liver biopsy - EUS guided

Percutaneous liver biposy

Description:

Patients having liver biopsy percutaneously

Treatment:

Diagnostic Test: Liver biopsy - percutaneous

Transjugular liver biopsy

Description:

Patients having liver biopsy via a transjugular route

Treatment:

Diagnostic Test: Liver biopsy - transjugular