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Completed

NCT Number: NCT05118308

EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

Primary outcomes

  1. Compare the proportion of adequate Liver Biopsy specimens with reliable portal pressure gradient obtained by TJ or EUS

    Time frame: 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 outcomes

  1. Technical success

    Time frame: 1 day

    Compare the proportion of HVPG and LB obtained by TJ or EUS approach

  2. Liver biopsy-related outcomes

    Time frame: 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.

  3. PPG-related outcomes

    Time frame: 1 day

    Number of PPG obtained, number of reliable PPG obtained

  4. Adverse events

    Time frame: 30 days

    Proportion of adverse events in the TJ and EUS arms following the procedure, at day 7, and day 30.

  5. Satisfaction with sedation

    Time frame: 1 day

    Compare the score obtained on the sedation satisfaction surveys as completed by the participant and the physician within the 2 arms

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Nov 11, 2021
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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