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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-31

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Chronic Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Amine Benmassaoud

Division of Gastroenterology and Hepatology Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Amine Benmassaoud, MD

Role: CONTACT

Phone: 514-934-1934

Email: [email protected]

Olivia Geraci, BSc