Advanced Chronic Liver DiseaseNCT06181409
LSM and SSM for the Diagnosis of CSPH: a Prospective Cohort Study
An observational study of Advanced Chronic Liver Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The goal of this observational study is to assess non-invasive tools' efficacy in predicting portal hypertension-related complications in individuals with advanced chronic liver disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Chronic Liver Disease
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with advanced chronic liver disease (defined as LSM ≥ 10kPa)
Who may be able to join
- Age above 18years old
- Advanced chronic liver disease (defined as LSM ≥ 10kPa)
- Ability to provide informed consent
Who cannot join
- Transjugular intrahepatic portosystemic shunt
- previous liver transplantation
- Abnormality of the porto-mesenteric system (portal vein thrombosis, splenic vein thrombosis, splenectomy, portal cavernomatous transformation, porto-caval shunts)
- Hematological malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H3G1A4
Amine Benmassaoud, MD, 5149341934, amine.benmassaoud@mcgill.ca
Myriam Martel, MSc, 5149341934, myriam.martel@muhc.mcgill.ca
About this study
Official title: Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study
The goal of this observational study is to assess non-invasive tools' efficacy in predicting portal hypertension-related complications in individuals with advanced chronic liver disease. The main question it aims to answer are:
- what are the cut-off values for non-invasive tests (NITs) (including LSM, SSM) that predict the presence and occurrence of hepatic decompensation in individuals with advanced chronic liver disease?
Participants will undergo regular study visits involving non-invasive tests (LSM, SSM) and assessments to monitor hepatic decompensation over the study period.
- Conditions
- Advanced Chronic Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients diagnosed with portal hypertension using elastography techniques
We will assess the diagnostic accuracy of liver and spleen stiffness measurements for portal hypertension
Measured: At baseline
Secondary outcomes (1)
Identifying patients at high-risk of liver related events using elastography techniques
We will use liver and spleen stiffness measurements to identify patients at risk of developing liver -related events
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start10 Jan 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Chronic Liver DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
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
- NCT06181409
- Sponsor's protocol ID
- MP-2022-8165
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06181409
- Acronym / sponsor ID
- MP-2022-8165
- Conditions
- Advanced Chronic Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Dec 2023 (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.
The goal of this observational study is to assess non-invasive tools' efficacy in predicting portal hypertension-related complications in individuals with advanced chronic liver disease. The main question it aims to answer are:
- what are the cut-off values for non-invasive tests (NITs) (including LSM, SSM) that predict the presence and occurrence of hepatic decompensation in individuals with advanced chronic liver disease?
Participants will undergo regular study visits involving non-invasive tests (LSM, SSM) and assessments to monitor hepatic decompensation over the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with advanced chronic liver disease (defined as LSM ≥ 10kPa)
Key inclusion criteria (3 listed)
- Age above 18years old
- Advanced chronic liver disease (defined as LSM ≥ 10kPa)
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Transjugular intrahepatic portosystemic shunt
- previous liver transplantation
- Abnormality of the porto-mesenteric system (portal vein thrombosis, splenic vein thrombosis, splenectomy, portal cavernomatous transformation, porto-caval shunts)
- Hematological malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients diagnosed with portal hypertension using elastography techniques
Time frame: At baseline
We will assess the diagnostic accuracy of liver and spleen stiffness measurements for portal hypertension
1 secondary outcome
Identifying patients at high-risk of liver related events using elastography techniques
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Mar 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amine Benmassaoud, MD (514-934-1934, amine.benmassaoud@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients diagnosed with portal hypertension using elastography techniques (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2026.