EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement

Not Applicable

Active, not recruiting

• Conditions: Chronic Liver Disease; Cirrhosis; Portal Hypertension
• Interventions: Procedure: Transjugular hepatic venous pressure gradient measurement with liver biopsy; Procedure: Endoscopic ultrasound portal pressure gradient measurement with liver biopsy

• Registration Number: NCT05118308
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-22
• Study Start: 2021-11-04
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-11
• Status Verified: 2024-12
• Primary Completion: 2024-12-01
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transjugular approach	Transjugular hepatic venous pressure gradient measurement with liver biopsy	Transjugular hepatic venous pressure gradient measurement with liver biopsy (HVPG-LB).
Endoscopic ultrasound approach	Endoscopic ultrasound portal pressure gradient measurement with liver biopsy	Endoscopic ultrasound portal pressure gradient measurement with liver biopsy (EUS-PPG-LB)

Primary Outcome Measures

Name	Time	Method
Compare the proportion of adequate Liver Biopsy specimens with reliable portal pressure gradient obtained by TJ or EUS	2 weeks	Liver Biopsy (LB) specimens are defined as a biopsy of at least 25mm in length following formalin fixation and at least 11 complete portal tracts. The Portal pressure gradient (PPG) measurement is defined as two PPG values with less than 2mmHg difference.

Secondary Outcome Measures

Name	Time	Method
Adverse events	30 days	Proportion of adverse events in the TJ and EUS arms following the procedure, at day 7, and day 30.
PPG-related outcomes	1 day	Number of PPG obtained, number of reliable PPG obtained
Liver biopsy-related outcomes	2 weeks	Number of adequate liver biopsies obtained, total aggregate length (defined as the sum of the lengths of all specimens following fixation), number of complete portal tracts per specimen, and total number of passes needed.
Technical success	1 day	Compare the proportion of HVPG and LB obtained by TJ or EUS approach
Satisfaction with sedation	1 day	Compare the score obtained on the sedation satisfaction surveys as completed by the participant and the physician within the 2 arms

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada