Liver and spleen stiffness testing to diagnose clinically significant portal hypertension
Official title: Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study
Run by McGill University Health Centre/Research Institute of the McGill University Health Centre · NCT06181409 · Data updated 2026-11-12
This project tests whether liver and spleen stiffness measurements can predict portal-hypertension complications in adults with advanced chronic liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | McGill University Health Centre/Research Institute of the McGill University Health Centre Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Status | Recruiting |
| Started | January 10, 2024 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | March 12, 2026 |
| Trial ID | NCT06181409 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with advanced chronic liver disease (LSM ≥ 10 kPa) who can give informed consent and can attend follow-up visits are ideal candidates.
✕Probably not a fit
Patients with prior transjugular intrahepatic portosystemic shunt (TIPS), previous liver transplantation, porto-mesenteric abnormalities, hematologic malignancy, or those without advanced fibrosis (LSM < 10 kPa) are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational cohort that will follow adults with advanced chronic liver disease over time and perform repeated non-invasive liver (LSM) and spleen (SSM) stiffness measurements. Participants will undergo regular clinic visits with elastography and clinical assessments to record occurrences of hepatic decompensation. The study aims to determine threshold cut-off values of these non-invasive tests that best predict presence and future occurrence of decompensation. Patients with prior TIPS, liver transplant, or porto-mesenteric abnormalities are excluded to focus on a representative advanced chronic liver disease population.
Why it matters
Potential benefit: If successful, clinicians could use non-invasive liver and spleen stiffness tests to identify patients at high risk for decompensation and avoid invasive pressure measurements.
How similar studies have gone: Prior research has shown promising correlations between liver and spleen stiffness and portal hypertension or varices, but optimal cut-off values to predict hepatic decompensation remain uncertain.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age above 18years old * Advanced chronic liver disease (defined as LSM ≥ 10kPa) * Ability to provide informed consent Exclusion Criteria: * 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
Where it's running
-
McGill University Health Centre
Montreal, Quebec, Canada Recruiting
Study contacts
- Study coordinator: Amine Benmassaoud, MD
- Email: amine.benmassaoud@mcgill.ca
- Phone: 514-934-1934
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.