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

RECRUITINGN/ASponsored by Carol Davila University of Medicine and Pharmacy
Actively Recruiting
PhaseN/A
SponsorCarol Davila University of Medicine and Pharmacy
Started2024-05-06
Est. completion2024-12
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Diffuse parenchymal liver disease with indication for liver biopsy for diagnostic and/or staging purposes,
* Eligibility for deep sedation with propofol
* Age above 18 years old
* Informed consent

Exclusion Criteria:

* Coagulation disorders which cannot be corrected
* Anticoagulant and/or antiagregant medication which cannot be stopped temporarily.
* Contraindications for liver biopsy, to local lidocaine anesthesia and to deep propofol sedation
* Absence of written informed consent

Conditions2

Liver DiseaseLiver Disease Parenchymal

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