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

Advanced Chronic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06181409
• Other study ID #: MP-2022-8165
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: December 2028

Study information

• Verified date: December 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Amine Benmassaoud, MD
• Phone: 514-934-1934
• Email: amine.benmassaoud[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Chronic Liver Disease
• Hypertension
• Hypertension, Portal
• Liver Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients diagnosed with portal hypertension using elastography techniques	We will assess the diagnostic accuracy of liver and spleen stiffness for portal hypertension	At baseline
Secondary	Identifying patients at high-risk of liver related events using elastography techniques	We will use liver and spleen stiffness to identify patients at risk of developing liver -related events	5 years