NCT06181409

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Dec 2028

First Submitted

Initial submission to the registry

December 1, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
15 days until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

December 1, 2023

Last Update Submit

March 10, 2026

Conditions

Advanced Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

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

    5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Age above 18years old
  • Advanced chronic liver disease (defined as LSM ≥ 10kPa)
  • Ability to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3G1A4, Canada

RECRUITING

Central Study Contacts

Amine Benmassaoud, MD

CONTACT

514-934-1934amine.benmassaoud@mcgill.ca

Olivia Geraci, BSc

CONTACT

514-934-1934olivia.geraci@muhc.mcgill.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Division of Gastroenterology and Hepatology Assistant Professor of Medicine

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 26, 2023

Study Start

January 10, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)