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LSM and SSM for the Diagnosis of CSPH: a Prospective Cohort Study

Diagnosing and Monitoring Portal Hypertension Non-invasively Using Spleen Stiffness Measurement in Patients With Advanced Chronic Liver Disease: a Prospective Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06181409
Enrollment
200
Registered
2023-12-26
Start date
2024-01-10
Completion date
2028-12-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Chronic Liver Disease

Brief 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. 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.

Interventions

None listed

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients diagnosed with portal hypertension using elastography techniquesAt baselineWe will assess the diagnostic accuracy of liver and spleen stiffness measurements for portal hypertension

Secondary

MeasureTime frameDescription
Identifying patients at high-risk of liver related events using elastography techniques5 yearsWe will use liver and spleen stiffness measurements to identify patients at risk of developing liver -related events

Countries

Canada

Contacts

CONTACTAmine Benmassaoud, MD
amine.benmassaoud@mcgill.ca514-934-1934
CONTACTOlivia Geraci, BSc
olivia.geraci@muhc.mcgill.ca514-934-1934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026