EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement

McGill University

Status: Active, not recruiting

Conditions: Portal Hypertension; Chronic Liver Disease; Cirrhosis

Treatments: Procedure: Transjugular hepatic venous pressure gradient measurement with liver biopsy; Procedure: Endoscopic ultrasound portal pressure gradient measurement with liver biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05118308

2021.7601

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Transjugular approach

Experimental group

Description:

Transjugular hepatic venous pressure gradient measurement with liver biopsy (HVPG-LB).

Treatment:

Procedure: Transjugular hepatic venous pressure gradient measurement with liver biopsy

Endoscopic ultrasound approach

Experimental group

Description:

Endoscopic ultrasound portal pressure gradient measurement with liver biopsy (EUS-PPG-LB)

Treatment:

Procedure: Endoscopic ultrasound portal pressure gradient measurement with liver biopsy