Recruiting

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

Sponsor:

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

Code:

NCT06181409

Conditions

Advanced Chronic Liver Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Advanced Chronic Liver Disease

Study ID

NCT06181409

Start date

Jan 10, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

Number of patients diagnosed with portal hypertension using elastography techniques [ Time Frame: At baseline ]

Central Contacts and Locations

Central contacts

Amine Benmassaoud, MD

514-934-1934 amine.benmassaoud@mcgill.ca

Olivia Geraci, BSc

514-934-1934 olivia.geraci@muhc.mcgill.ca

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H3G1A4

Contacts

Amine Benmassaoud, MD

5149341934 amine.benmassaoud@mcgill.ca

Myriam Martel, MSc

5149341934 myriam.martel@muhc.mcgill.ca

More Information

Sponsor

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

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2026-03-12.