Portal HypertensionNCT05118308
EUS vs TJ for Liver Biopsy and Portal Pressure Gradient Measurement
A study testing Transjugular hepatic venous pressure gradient measurement with liver biopsy and Endoscopic ultrasound portal pressure gradient measurement with liver biopsy in people with Portal Hypertension and Chronic Liver Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Portal Hypertension, Chronic Liver Disease, Cirrhosis
- What is being tested?
- Transjugular hepatic venous pressure gradient measurement with liver biopsy and Endoscopic ultrasound portal pressure gradient measurement with liver biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 4 Nov 2021to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- Intrahepatic portal vein thrombosis
- Previous liver transplantation
- Past hypersensitivity reaction to midazolam or ketamine
- History of psychotic disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Portal Hypertension, Chronic Liver Disease, Cirrhosis
- Being tested
- Transjugular hepatic venous pressure gradient measurement with liver biopsy, Endoscopic ultrasound portal pressure gradient measurement with liver biopsy
- Keywords
- eus-portal pressure gradient, eus-liver biopsies, liver biopsy, portal pressure gradient, hepatic venous pressure gradient, transjugular-portal pressure gradient, Transjugular-Liver biopsies
- Medical subject headings
- Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular hepatic venous pressure gradient measurement with liver biopsyProcedure or surgery
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 biopsyProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Transjugular approach | Experimental | Transjugular hepatic venous pressure gradient measurement with liver biopsy (HVPG-LB). Receives: 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) Receives: Procedure: Endoscopic ultrasound portal pressure gradient measurement with liver biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (5)
Technical success
Compare the proportion of HVPG and LB obtained by TJ or EUS approach
Measured: 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.
Measured: 2 weeks
PPG-related outcomes
Number of PPG obtained, number of reliable PPG obtained
Measured: 1 day
Adverse events
Proportion of adverse events in the TJ and EUS arms following the procedure, at day 7, and day 30.
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start4 Nov 2021
- Primary completion1 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amine Benmassaoud, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118308
- Sponsor's protocol ID
- 2021.7601
- Status last verified
- Apr 2026
- First submitted
- 22 Oct 2021
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2026 Jun;24(6):1601-1610. doi: 10.1016/j.cgh.2025.09.025. Epub 2025 Oct 3.
PubMed 41046961
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Gradient Measurement Compared to the Transjugular Approach: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05118308
- Acronym / sponsor ID
- 2021.7601
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transjugular approach | Experimental | Procedure: Transjugular hepatic venous pressure gradient measurement with liver biopsyTransjugular hepatic venous pressure gradient measurement with liver biopsy (HVPG-LB). |
| Endoscopic ultrasound approach | Experimental | Procedure: Endoscopic ultrasound portal pressure gradient measurement with liver biopsyEndoscopic ultrasound portal pressure gradient measurement with liver biopsy (EUS-PPG-LB) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transjugular hepatic venous pressure gradient measurement with liver biopsyThis 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. | Procedure or surgery | Transjugular approach |
| Endoscopic ultrasound portal pressure gradient measurement with liver biopsyA 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). | Procedure or surgery | Endoscopic ultrasound approach |
Primary outcome
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.
5 secondary outcomes
Technical success
Time frame: 1 day
Liver biopsy-related outcomes
Time frame: 2 weeks
PPG-related outcomes
Time frame: 1 day
Adverse events
Time frame: 30 days
Satisfaction with sedation
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Results publication: PubMed 41046961Benmassaoud 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. 2026 Jun;24(6):1601-1610. doi: 10.1016/j.cgh.2025.09.025. Epub 2025 Oct 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transjugular hepatic venous pressure gradient measurement with liver biopsy and Endoscopic ultrasound portal pressure gradient measurement with liver biopsy in people with Portal Hypertension and Chronic Liver Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the proportion of adequate Liver Biopsy specimens with reliable portal pressure gradient obtained by TJ or EUS (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.