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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:
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;
Dissemination plan:
the results of the study will be disseminated through presentation at national/ international meetings and publishing in peer reviewed journals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS guided liver biopsy | Patients having liver biopsy through endoscopic ultrasound technique |
| |
| Percutaneous liver biposy | Patients having liver biopsy percutaneously |
| |
| Transjugular liver biopsy | Patients having liver biopsy via a transjugular route |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver biopsy - percutaneous | Diagnostic Test | liver biopsy obtained using percutaneous ultrasound guided technique |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- under 18 years of age
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This is a prospective observation of all consecutive adult patients undergoing Liver biopsy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suresh Vasan Venkatachalapathy | Contact | 07966968417 | suresh.venkatachalapathy@nuh.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Suresh Vasan Suresh Vasan | Nottingham University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham University Hospitals NHS Trust | Recruiting | Nottingham | Ng7 2UH | United Kingdom |
no plan to share IPD
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liver biopsy
| Liver biopsy - transjugular | Diagnostic Test | liver biopsy obtained using an interventional transjugular approach |
|
| liver biopsy - EUS guided | Diagnostic Test | liver biopsy obtained during endoscopic ultrasound |
|
| 30 days |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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