EUS + Liver Biopsy for Liver Disease

Not currently recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for performing liver biopsies and measuring liver pressure using endoscopic ultrasound (EUS). The researchers aim to determine if this method matches or surpasses the traditional approach through the neck veins. Individuals with chronic liver disease or liver pressure issues, who are scheduled for a liver biopsy, may qualify for this study. Participants will be randomly assigned to one of two groups, each testing a different method. As an unphased trial, this study allows participants to contribute to innovative research that could enhance liver biopsy procedures.

Do I need to stop taking my current medications for the trial?

If you are on anticoagulation or antiplatelet therapy, you will need to stop taking them if they can be safely discontinued. For other medications, the trial protocol does not specify any requirements.

What prior data suggests that these methods are safe for liver biopsy and pressure measurement?

Research shows that procedures using endoscopic ultrasound are generally safe. Studies have found this method effective and safe for liver biopsies and checking blood pressure in the liver, offering a good alternative to other types of liver biopsies.

For transjugular liver biopsies, research indicates that this method is important and reliable for assessing liver health. It works well for patients, especially those without severe liver damage, and is also safe for measuring liver pressure in people with chronic liver issues.

Both methods have been studied and proven safe for patients, with strong evidence supporting their use for liver assessments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two innovative methods for assessing liver disease: the endoscopic ultrasound approach and the transjugular approach. Unlike traditional methods, the endoscopic ultrasound technique allows for a direct measurement of portal pressure, potentially providing a more accurate assessment of liver health. Meanwhile, the transjugular approach offers a less invasive way to measure hepatic venous pressure, which could improve patient comfort and reduce recovery time. By comparing these methods, the trial aims to find more precise and patient-friendly options for diagnosing and managing liver conditions.

What evidence suggests that this trial's approaches could be effective for liver disease?

In this trial, participants will undergo one of two methods for liver assessment. The endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement with liver biopsy is one approach under study. Previous studies have shown that EUS-PPG safely and effectively checks blood pressure in the liver, closely matching the standard transjugular method. The transjugular hepatic venous pressure gradient measurement with liver biopsy is the other approach in this trial. Research shows that the transjugular method reliably measures liver biopsy and pressure, with good success rates, especially in patients without severe liver damage. Both methods are valuable for understanding liver conditions, with EUS-PPG emerging as a promising alternative to the traditional transjugular approach. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11107402/

Endoscopic ultrasound-guided portal pressure gradient ... EUS-PPG is a new modality where the portal pressure is measured by directly introducing a needle into the hepatic vein and portal vein.

2. frontiersin.org frontiersin.org/journals/gastroenterology/articles/10.3389/fgstr.2023.1209539/full

The safety and efficacy of endoscopic ultrasound-guided ... EUS-PPG measurement is safe and useful in providing an assessment of portal pressure in patients with chronic liver disease.

3. cghjournal.org cghjournal.org/article/S1542-3565(25)00078-3/abstract

Endoscopic Ultrasound–Guided Portosystemic Pressure ... EUS-PPG measurement was technically feasible and safe and demonstrated a strong correlation with clinical parameters of PH and liver histology.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1542356525000783

Endoscopic Ultrasound–Guided Portosystemic Pressure ... EUS-PPG measurement was technically feasible and safe and demonstrated a strong correlation with clinical parameters of PH and liver histology.

5. jhep-reports.eu jhep-reports.eu/article/S2589-5559(25)00144-2/fulltext

Endoscopic ultrasound-guided portosystemic pressure ... EUS-PPG is a direct alternative to HVPG for portal pressure measurement. •. EUS-guided portal pressure strongly correlates with transjugular portal pressure ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35513894/

Endoscopic ultrasound-guided portal pressure gradient ... EUS-guided liver biopsy (EUS-bx) has been shown to be a safe and effective alternative to percutaneous or Interventional Radiology-guided liver biopsy.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12276445/

Endoscopic ultrasound-guided portosystemic pressure ... Patients with cirrhosis and portal hypertension are at increased risk of hepatic decompensation and liver-related mortality.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05118308

EUS vs TJ for Liver Biopsy and Portal Pressure Gradient ... This study will directly compare the endoscopic ultrasound guided approach to obtain adequate liver biopsies and portal pressure gradient measurements to the ...