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

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 Overview

• Status: Recruiting
• Conditions: Advanced Chronic Liver Disease

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Amine Benmassaoud, MD; Phone Number: 514-934-1934; Email: amine.benmassaoud@mcgill.ca
• Study Contact Backup: Name: Olivia Geraci, BSc; Phone Number: 34868 514-934-1934; Email: olivia.geraci@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3G1A4
      • Recruiting
      • McGill University Health Centre
      • Contact: Amine Benmassaoud, MD; Phone Number: 5149341934; Email: amine.benmassaoud@mcgill.ca
      • Contact: Myriam Martel, MSc; Phone Number: 5149341934; Email: myriam.martel@muhc.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adults with advanced chronic liver disease (defined as LSM ≥ 10kPa)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 years

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Hypertension; Hypertension, Portal
• Other Study ID Numbers: MP-2022-8165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No