EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement

  • STATUS
    Recruiting
  • End date
    Dec 4, 2023
  • participants needed
    58
  • sponsor
    McGill University Health Centre/Research Institute of the McGill University Health Centre
Updated on 13 December 2021
hypertension
venous pressure
liver disease
hepatic venous pressure gradient
biopsy of liver
Accepts healthy volunteers

Summary

This study will directly compare the endoscopic ultrasound guided approach to obtain adequate liver biopsies and portal pressure gradient measurements to the current standard of care which uses the transjugular approach.

Description

Current guidelines recommend that when a hepatic venous pressure gradient and a liver biopsy are needed, the liver biopsy should be done by the transjugular approach during the same session. A major limitation is that liver biopsies obtained by the transjugular approach meet quality criteria proposed by the American Association for the Study of Liver Diseases (at least 2-3cm with at least 11 complete portal tracts) in only 40% of cases.

Recent studies have shown that endoscopic ultrasound-guided liver biopsy (EUS-LB) can achieve a high rate of adequate liver biopsies using the same strict criteria described above. In addition, a novel endoscopic-ultrasound adapted manometer allows the safe and accurate measurement of portal pressure gradient (PPG) which correlates well with hepatic venous pressures (HVPG) obtained by the transjugular approach. Unfortunately to this day, no randomized controlled trials has compared the EUS-LB and PPG vs TJ-LB and HVPG directly.

Details
Condition Portal Hypertension, Chronic Liver Disease, Cirrhosis
Treatment Transjugular hepatic venous pressure gradient measurement with liver biopsy, Endoscopic ultrasound portal pressure gradient measurement with liver biopsy
Clinical Study IdentifierNCT05118308
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
Last Modified on13 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age above 18 years
Undergoing evaluation for chronic liver disease or portal hypertension
Planned to undergo a liver biopsy and HVPG by their treating hepatologist for clinical purposes
Signed informed consent

Exclusion Criteria

Uncorrectable coagulopathy (INR above 1.5)
Uncorrectable thrombocytopenia (Platelets under 50,000)
Anticoagulation or antiplatelet therapy that cannot be discontinued
Surgically altered upper digestive anatomy
Biliary obstruction
Grade II ascites or more
Intrahepatic portal vein thrombosis
Previous liver transplantation
Past hypersensitivity reaction to midazolam or ketamine
History of psychotic disorder
Pregnancy
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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