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EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement

NCT ID: NCT05118308

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-04

Study Completion Date

2025-01-01

Brief Summary

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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

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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

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Portal Hypertension Chronic Liver Disease Cirrhosis

Keywords

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eus-portal pressure gradient eus-liver biopsies liver biopsy portal pressure gradient hepatic venous pressure gradient transjugular-portal pressure gradient Transjugular-Liver biopsies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors
As EUS and TJ procedures are inherently different, patients and health-care workers directly involved in the procedure, including nurses, physicians, and technicians, will not be blinded. Pathologists interpreting liver biopsies will be blinded to the intervention group.

Study Groups

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Transjugular approach

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

Group Type EXPERIMENTAL

Transjugular hepatic venous pressure gradient measurement with liver biopsy

Intervention Type PROCEDURE

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.

Endoscopic ultrasound approach

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

Group Type EXPERIMENTAL

Endoscopic ultrasound portal pressure gradient measurement with liver biopsy

Intervention Type PROCEDURE

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).

Interventions

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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.

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Amine Benmassaoud

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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McGill University Health Centre

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2021.7601

Identifier Type: -

Identifier Source: org_study_id