Clinical trial NCT05912179: Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy
Official title: Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Diseases
Liver Fibrosis
Keywords: EUS
Endoscopic Ultrasound
Liver Biopsy
Percutaneous liver biopsy
Trans-jugular liver biopsy
EUS shear wave measurement
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective observation of all consecutive adult patients undergoing Liver biopsy.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

- under 18 years of age

Primary outcomes:
measure: proportion of patients with adquate tissue to make accurate diagnosis with different modalities of Liver biopsy
timeFrame: 1 year
Secondary outcomes:
measure: Length of stay
timeFrame: 1 year
measure: Complication rate with different modalities
timeFrame: 30 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Nottingham University Hospitals
name: Suresh Vasan Suresh Vasan
role: PRINCIPAL_INVESTIGATOR
References: