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

Study Overview
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Brief Summary
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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: is EUS liver biopsy equally as good as other types of techniques 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.

Detailed Description
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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; Technical success rate, Length of the cores obtained Number of portal tracts Accuracy of Shear wave measurement compared to Liver biopsy complications rate 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.

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

Conditions
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Liver Diseases, Liver Fibrosis

Intervention / Treatment
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* Diagnostic Test: Liver biopsy - percutaneous
* Diagnostic Test: Liver biopsy - transjugular
* Diagnostic Test: liver biopsy - EUS guided


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older underwent liver biopsy either through EUS, percutaneous or transjugular route Exclusion Criteria: - under 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EUS guided liver biopsy<br>Patients having liver biopsy through endoscopic ultrasound technique | Diagnostic Test: liver biopsy - EUS guided<br>* liver biopsy obtained during endoscopic ultrasound<br>|
| Percutaneous liver biposy<br>Patients having liver biopsy percutaneously | Diagnostic Test: Liver biopsy - percutaneous<br>* liver biopsy obtained using percutaneous ultrasound guided technique<br>|
| Transjugular liver biopsy<br>Patients having liver biopsy via a transjugular route | Diagnostic Test: Liver biopsy - transjugular<br>* liver biopsy obtained using an interventional transjugular approach<br>|

What is the study measuring?
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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 | 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 | length of stay of patients undergoing different Liver biopsy modalities | 1 year | 
| Complication rate with different modalities | complication rate of different modalities of liver biopsy | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Biopsy, EUS, Endoscopic Ultrasound, Percutaneous liver biopsy, Trans-jugular liver biopsy, EUS shear wave measurement