Liver DiseasesNCT05912179
Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy
An observational study of Liver Diseases and Liver Fibrosis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Diseases, Liver Fibrosis
- What is being tested?
- Liver biopsy - percutaneous, Liver biopsy - transjugular and liver biopsy - EUS guided
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2022to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a prospective observation of all consecutive adult patients undergoing Liver biopsy.
Who may be able to join
- 18 years or older
- underwent liver biopsy either through EUS, percutaneous or transjugular route
Who cannot join
- under 18 years of age
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Nottingham University Hospitals NHS Trust
Nottingham, Ng7 2UH
Suresh V Venkatachalapathy, MRCP, 01159249924 ext. 70441, suresh.venkatachalapathy@nuh.nhs.uk
About this study
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.
Read the 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;
- 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.
- Conditions
- Liver Diseases, Liver Fibrosis
- Being tested
- Liver biopsy - percutaneous, Liver biopsy - transjugular, liver biopsy - EUS guided
- Keywords
- EUS, Endoscopic Ultrasound, Liver Biopsy, Percutaneous liver biopsy, Trans-jugular liver biopsy, EUS shear wave measurement
- Medical subject headings
- Liver Diseases, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver biopsy - percutaneousDiagnostic test
liver biopsy obtained using percutaneous ultrasound guided technique
Liver biopsy - transjugularDiagnostic test
liver biopsy obtained using an interventional transjugular approach
liver biopsy - EUS guidedDiagnostic test
liver biopsy obtained during endoscopic ultrasound
| Study group | Role | What they receive |
|---|---|---|
| EUS guided liver biopsy | Patients having liver biopsy through endoscopic ultrasound technique Receives: Diagnostic Test: liver biopsy - EUS guided | |
| Percutaneous liver biposy | Patients having liver biopsy percutaneously Receives: Diagnostic Test: Liver biopsy - percutaneous | |
| Transjugular liver biopsy | Patients having liver biopsy via a transjugular route Receives: Diagnostic Test: Liver biopsy - transjugular |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Length of stay
length of stay of patients undergoing different Liver biopsy modalities
Measured: 1 year
Complication rate with different modalities
complication rate of different modalities of liver biopsy
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Sep 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suresh Vasan Venkatachalapathy, Nottingham University Hospitals NHS Trust
- Investigators
- Suresh Vasan Suresh Vasan, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912179
- Sponsor's protocol ID
- 22-577C
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy
- ClinicalTrials.gov ID
- NCT05912179
- Acronym / sponsor ID
- 22-577C
- Conditions
- Liver Diseases, Liver Fibrosis
- Keywords
- EUS, Endoscopic Ultrasound, Liver Biopsy, Percutaneous liver biopsy, Trans-jugular liver biopsy, EUS shear wave measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EUS guided liver biopsy | – | Diagnostic Test: liver biopsy - EUS guidedPatients having liver biopsy through endoscopic ultrasound technique |
| Percutaneous liver biposy | – | Diagnostic Test: Liver biopsy - percutaneousPatients having liver biopsy percutaneously |
| Transjugular liver biopsy | – | Diagnostic Test: Liver biopsy - transjugularPatients having liver biopsy via a transjugular route |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observation of all consecutive adult patients undergoing Liver biopsy.
Key inclusion criteria (2 listed)
- 18 years or older
- underwent liver biopsy either through EUS, percutaneous or transjugular route
Key exclusion criteria (1 listed)
- under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver biopsy - percutaneousliver biopsy obtained using percutaneous ultrasound guided technique | Diagnostic test | Percutaneous liver biposy |
| Liver biopsy - transjugularliver biopsy obtained using an interventional transjugular approach | Diagnostic test | Transjugular liver biopsy |
| liver biopsy - EUS guidedliver biopsy obtained during endoscopic ultrasound | Diagnostic test | EUS guided liver biopsy |
Primary outcome
proportion of patients with adquate tissue to make accurate diagnosis with different modalities of Liver biopsy
Time frame: 1 year
patient in whom a diagnosis has been reached or supported by histological results
2 secondary outcomes
Length of stay
Time frame: 1 year
Complication rate with different modalities
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No. no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suresh Vasan Suresh Vasan principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases and Liver Fibrosis, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suresh Vasan Venkatachalapathy (07966968417, suresh.venkatachalapathy@nuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with adquate tissue to make accurate diagnosis with different modalities of Liver biopsy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 27 Oct 2026.