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

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Portal Hypertension; Chronic Liver Disease
• Intervention / Treatment: Procedure: Transjugular hepatic venous pressure gradient measurement with liver biopsy; Procedure: Endoscopic ultrasound portal pressure gradient measurement with liver biopsy

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G1A4
      • McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transjugular approach; Transjugular hepatic venous pressure gradient measurement with liver biopsy (HVPG-LB).	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.
Experimental: Endoscopic ultrasound approach; Endoscopic ultrasound portal pressure gradient measurement with liver biopsy (EUS-PPG-LB)	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the proportion of adequate Liver Biopsy specimens with reliable portal pressure gradient obtained by TJ or EUS	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.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Compare the proportion of HVPG and LB obtained by TJ or EUS approach	1 day
Liver biopsy-related outcomes	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.	2 weeks
PPG-related outcomes	Number of PPG obtained, number of reliable PPG obtained	1 day
Adverse events	Proportion of adverse events in the TJ and EUS arms following the procedure, at day 7, and day 30.	30 days
Satisfaction with sedation	Compare the score obtained on the sedation satisfaction surveys as completed by the participant and the physician within the 2 arms	1 day

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

General Publications

• Benmassaoud A, Bessissow A, Samoukovic G, Wong P, Zhao X, Deschenes M, Sebastiani G, Cabrera T, Valenti D, Boucher LM, Pelage JP, Muchantef K, Cardenas A, Givis MA, White S, Bousquet-Dion G, Waked C, Jacques J, Rahme E, Geraci O, Martel M, Barkun A, Maedler-Kron C, Chen YI. EUS-Guided Liver Biopsy and Portal Pressure Measurement Compared With a Transjugular Approach: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025 Oct 3:S1542-3565(25)00850-X. doi: 10.1016/j.cgh.2025.09.025. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: liver biopsy; eus-portal pressure gradient; eus-liver biopsies; portal pressure gradient; hepatic venous pressure gradient; transjugular-portal pressure gradient; Transjugular-Liver biopsies
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Pathological Conditions, Signs and Symptoms; Fibrosis; Hypertension, Portal; Hematinics; Liver Extracts
• Other Study ID Numbers: 2021.7601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes