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EUS + Liver Biopsy for Liver Disease
N/A
Waitlist Available
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two methods for liver biopsy and measuring portal pressure.
Who is the study for?
This trial is for adults over 18 who need a liver biopsy and portal pressure measurement due to chronic liver disease or portal hypertension. It's not for those on certain blood thinners, with altered digestive anatomy, severe fluid in the abdomen, liver vein clots, past liver transplant, allergy to specific sedatives, psychotic disorders, pregnancy, or significant clotting or platelet issues.
What is being tested?
The study compares two methods of measuring portal pressure and obtaining liver biopsies: an endoscopic ultrasound (EUS) approach versus the standard transjugular (TJ) hepatic venous method. The goal is to see which one provides better results as part of patient care.
What are the potential side effects?
Potential side effects may include discomfort at the biopsy site, bleeding risks especially if there are existing clotting problems; reactions to sedatives used during procedures like midazolam or ketamine; and complications related to underlying health conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Compare the proportion of adequate Liver Biopsy specimens with reliable portal pressure gradient obtained by TJ or EUS
Secondary study objectives
Adverse events
Biopsy
PPG-related outcomes
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Transjugular approachExperimental Treatment1 Intervention
Transjugular hepatic venous pressure gradient measurement with liver biopsy (HVPG-LB).
Group II: Endoscopic ultrasound approachExperimental Treatment1 Intervention
Endoscopic ultrasound portal pressure gradient measurement with liver biopsy (EUS-PPG-LB)
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
471 Previous Clinical Trials
166,949 Total Patients Enrolled
2 Trials studying Liver Cirrhosis
34 Patients Enrolled for Liver Cirrhosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Endoscopic ultrasound approach
- Group 2: Transjugular approach
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.