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

NCT05912179 | Unknown

• 1 other identifier: 22-577C
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.is EUS liver biopsy equally as good as other types of techniques
2. 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.

Conditions

Liver Diseases; Liver Fibrosis

Keywords

EUS; Endoscopic Ultrasound; Liver Biopsy; Percutaneous liver biopsy; Trans-jugular liver biopsy; EUS shear wave measurement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Length of stay

  1 year

• Complication rate with different modalities

  30 days

Study Arms (3)

EUS guided liver biopsy

Patients having liver biopsy through endoscopic ultrasound technique

Diagnostic Test: liver biopsy - EUS guided

Percutaneous liver biposy

Patients having liver biopsy percutaneously

Diagnostic Test: Liver biopsy - percutaneous

Transjugular liver biopsy

Patients having liver biopsy via a transjugular route

Diagnostic Test: Liver biopsy - transjugular

Interventions

Liver biopsy - percutaneous DIAGNOSTIC_TEST

liver biopsy obtained using percutaneous ultrasound guided technique

Percutaneous liver biposy

Liver biopsy - transjugular DIAGNOSTIC_TEST

liver biopsy obtained using an interventional transjugular approach

Transjugular liver biopsy

liver biopsy - EUS guided DIAGNOSTIC_TEST

liver biopsy obtained during endoscopic ultrasound

EUS guided liver biopsy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective observation of all consecutive adult patients undergoing Liver biopsy.

You may qualify if:

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

You may not qualify if:

• \- under 18 years of age

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Ng7 2UH, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

liver biopsy

MeSH Terms

Conditions

Liver Diseases; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Suresh Vasan Suresh Vasan

  Nottingham University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suresh Vasan Venkatachalapathy

CONTACT

07966968417; suresh.venkatachalapathy@nuh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Hepatologist

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: September 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)