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NCT Number: NCT06181409

LSM and SSM for the Diagnosis of CSPH: 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.

Recruiting

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Key information

Conditions

Advanced Chronic Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Identifying patients at high-risk of liver related events using elastography techniques

    Time frame: 5 years

    We will use liver and spleen stiffness measurements to identify patients at risk of developing liver -related events

Study contacts

Contact information is provided by the study sponsor or research team.

Amine Benmassaoud, MD

CONTACT

[email protected]

514-934-1934

Olivia Geraci, BSc

CONTACT

[email protected]

514-934-1934 ext. 34868

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 26, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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