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

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05912179
• Other study ID #: 22-577C
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2023
• Source: Nottingham University Hospitals NHS Trust
• Contact: Suresh Vasan Venkatachalapathy
• Phone: 07966968417
• Email: suresh.venkatachalapathy[@]nuh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• 18 years or older

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

Exclusion Criteria:

• under 18 years of age

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Diseases
• Liver Fibrosis

Intervention

Diagnostic Test:
• Liver biopsy - percutaneous
liver biopsy obtained using percutaneous ultrasound guided technique
• Liver biopsy - transjugular
liver biopsy obtained using an interventional transjugular approach
• liver biopsy - EUS guided
liver biopsy obtained during endoscopic ultrasound

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Nottingham University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Length of stay	length of stay of patients undergoing different Liver biopsy modalities	1 year
Secondary	Complication rate with different modalities	complication rate of different modalities of liver biopsy	30 days