Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06231082

Bloody or Well Done. How Would You Like Your Liver Biopsy, Sir?

Led by Carol Davila University of Medicine and Pharmacy · Updated on 2024-05-07

78

Participants Needed

1

Research Sites

29 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a randomized comparative trial between percutaneous liver biopsy and EUS FNB guided liver biopsy in patients with parenchymal liver disease. Studies so far have been shown that EUS FNB guided liver biopsy is non inferior to percutaneous liver biopsy in terms of efficacy, provided several conditions are met (type of needle, wet suction, actuations). În terms of safety, it may be that EUS FNB have an advantage, as needle diameter is slightly smaller, needle is inserted under better visualisation especially in patients with large subcutaneous fat tissue and the possibility of examining the needle tract and plugging it with needle content if needed ("the blood patch technique"). However, although severe, the incidence of liver bleeding is low, so a comparative trial with the hypothesis that EUS FNB has fewer liver bleedings than percutaneous techniques would have a very large sample size. A recent study found out that abdominal pain at 2 hours after procedure is predictive for liver bleeding. So we have design a randomized prospective trial assuming that EUS FNB guided liver biopsy has significantly less abdominal pain at 2 hours after procedure when compared to percutaneous route, using abdominal pain at 2 hours as a surrogate marker for risk of liver bleeding.

CONDITIONS

Official Title

Bloody or Well Done. How Would You Like Your Liver Biopsy, Sir?

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of diffuse parenchymal liver disease requiring liver biopsy for diagnosis or staging
  • Eligible for deep sedation with propofol
  • Age above 18 years old
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Uncorrectable coagulation disorders
  • Use of anticoagulant or antiplatelet medications that cannot be temporarily stopped
  • Contraindications to liver biopsy, local lidocaine anesthesia, or deep propofol sedation
  • No written informed consent provided

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

"Prof. Dr. Agrippa Ionescu" Clinical and Emerency Hospital

Bucharest, Romania, 0112013

Actively Recruiting

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Research Team

M

Mihai Ciocirlan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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