NCT05118308

EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement

Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Gradient Measurement Compared to the Transjugular Approach: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Portal Hypertension
• Chronic Liver Disease
• Cirrhosis

Interventions

Type	Name	Description
PROCEDURE	Transjugular hepatic venous pressure gradient measurement with liver biopsy	This procedure will be performed by an experienced interventional radiologist who will be supported by a radiology technician and nurse. Transjugular hepatic venous pressure gradient measurement will be performed using standard procedure. Following this, a transjugular liver biopsy will be obtained using an 18-gauge transjugular liver biopsy needle.
PROCEDURE	Endoscopic ultrasound portal pressure gradient measurement with liver biopsy	A linear echoendoscope is inserted with the patient under conscious sedation. Using a through the scope 25-gauge needle connected to a digital manometer, portal and hepatic veins will be punctured under EUS guidance from a trans-gastric/hepatic approach. Following this, EUS-Liver biopsy is then performed immediately following EUS-PPG using a 19-gauge fine needle biopsy (FNB).

Timeline

• Start date: 2021-11-04
• Primary completion: 2024-12-01
• Completion: 2025-01-01
• First posted: 2021-11-11
• Last updated: 2026-04-17

Locations

1 site across 1 country: Canada