LSM and SSM for the Diagnosis of CSPH: a Prospective Coho... | NCT06181409

Studies
LSM and SSM for the Diagnosis of CSPH: a Prospective Cohort Study

NCT06181409

Sponsor

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

Status

Recruiting

Last Update Posted

Mar 12, 2026Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Advanced Chronic Liver Disease

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 10, 2024Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

Dec 1, 2023

First Submission Date that Met QC Criteria

Dec 12, 2023

First Posted Date

Dec 26, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2026

Last Update Posted Date

Mar 12, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amine Benmassaoud, Division of Gastroenterology and Hepatology Assistant Professor of Medicine, McGill University Health Centre/Research Institute of the McGill University Health CentrePrincipal Investigator

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amine Benmassaoud, MD	Contact	514-934-1934		amine.benmassaoud@mcgill.ca
Olivia Geraci, BSc	Contact	514-934-1934	34868	olivia.geraci@muhc.mcgill.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McGill University Health Centre	Recruiting	Montreal	Quebec	H3G1A4	Canada

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided