EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement

NCT05118308 | Completed DMC

• 1 other identifier: 2021.7601
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension; Chronic Liver Disease; Cirrhosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Technical success

  1 day

• Liver biopsy-related outcomes

  2 weeks

• PPG-related outcomes

  1 day

• Adverse events

  30 days

• Satisfaction with sedation

  1 day

Study Arms (2)

Transjugular approach

EXPERIMENTAL

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

Procedure: Transjugular hepatic venous pressure gradient measurement with liver biopsy

Endoscopic ultrasound approach

EXPERIMENTAL

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

Procedure: Endoscopic ultrasound portal pressure gradient measurement with liver biopsy

Interventions

Transjugular hepatic venous pressure gradient measurement with liver biopsy 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.

Transjugular approach

Endoscopic ultrasound portal pressure gradient measurement with liver biopsy 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).

Endoscopic ultrasound approach

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

Location

Related Publications (1)

• 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.

  PMID: 41046961 RESULT

MeSH Terms

Conditions

Hypertension, Portal; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 11, 2021
• Study Start: November 4, 2021
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)