EUS + Liver Biopsy for Liver Disease

Overseen By Amine Benmassaoud, MD

Age: 18+

Sex: Any

Trial Phase: Academic

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

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Coagulopathy, Thrombocytopenia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

58 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will directly compare the endoscopic ultrasound guided approach to obtain adequate liver biopsies and portal pressure gradient measurements to the current standard of care which uses the transjugular approach.

Eligibility Criteria

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.

Inclusion Criteria

Signed informed consent

Planned to undergo a liver biopsy and HVPG by their treating hepatologist for clinical purposes

Undergoing evaluation for chronic liver disease or portal hypertension

Exclusion Criteria

Anticoagulation or antiplatelet therapy that cannot be discontinued

Surgically altered upper digestive anatomy

Biliary obstruction

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either endoscopic ultrasound or transjugular approach for liver biopsy and portal pressure gradient measurement

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and satisfaction with sedation

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Endoscopic ultrasound portal pressure gradient measurement with liver biopsy
• Transjugular hepatic venous pressure gradient measurement with liver biopsy

Trial Overview 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.

Participant Groups

Group I: Transjugular approach Experimental Treatment 1 Intervention

Transjugular hepatic venous pressure gradient measurement with liver biopsy (HVPG-LB).

Group II: Endoscopic ultrasound approach Experimental Treatment 1 Intervention

Endoscopic ultrasound portal pressure gradient measurement with liver biopsy (EUS-PPG-LB)

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

476

Recruited

170,000+