EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement

Last updated: December 3, 2024
Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hepatitis C; Chronic

Liver Disease

Primary Biliary Cholangitis

Treatment

Endoscopic ultrasound portal pressure gradient measurement with liver biopsy

Transjugular hepatic venous pressure gradient measurement with liver biopsy

Clinical Study ID

NCT05118308
2021.7601
  • Ages 18-100
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 forclinical purposes

  • Signed informed consent

Exclusion

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

Study Design

Total Participants: 58
Treatment Group(s): 2
Primary Treatment: Endoscopic ultrasound portal pressure gradient measurement with liver biopsy
Phase:
Study Start date:
November 04, 2021
Estimated Completion Date:
January 01, 2025

Study 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.

Connect with a study center

  • McGill University Health Centre

    Montréal, Quebec H3G1A4
    Canada

    Site Not Available

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