Ultrasound-Guided Pressure Measurement for Liver Disease

Overseen By Zaid Haddadin, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Methodist Health System

Disqualifiers: Pregnancy, Endoscopy contraindication, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to measure liver pressure using ultrasound during liver biopsies. The goal is to determine if this method is effective and safe for individuals with liver disease or suspected cirrhosis (liver scarring). Participants should be undergoing an endoscopic ultrasound procedure, specifically the Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement, and have a history of liver issues or suspected cirrhosis. The trial seeks to find better ways to assess liver health and guide treatment decisions. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance liver health assessments and treatment strategies.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this method is safe for liver disease patients?

Research has shown that Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement (EUS-PPG) is safe for people with liver disease. Studies have found that this method effectively measures portal pressure, which is crucial for managing liver conditions. In one study, EUS-PPG was safely used on patients and helped assess the risk of complications like bleeding from swollen veins. Another study confirmed its safety and usefulness in evaluating long-term liver disease. To date, EUS-PPG has proven to be a reliable and safe option for patients needing detailed liver assessments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ultrasound-guided pressure measurement technique for liver disease because it offers a less invasive way to assess liver health compared to traditional methods. Unlike the standard practice of measuring portal pressure through invasive catheterization, this new technique uses endoscopic ultrasound to measure the portal pressure gradient directly. This approach reduces patient discomfort and risk, while providing accurate results. This advancement could lead to better management and monitoring of liver diseases, making it a promising development in hepatology.

What evidence suggests that Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement is effective for liver disease?

Research has shown that Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement (EUS-PPGM), which participants in this trial will undergo, effectively checks pressure in the portal vein of individuals with chronic liver disease. Studies have found that this method safely provides crucial details about portal vein pressure, essential for managing liver conditions. It can predict the outcomes of abdominal surgery and aligns well with other health indicators and liver health. EUS-PPGM also offers a promising way to diagnose portal hypertension (high blood pressure in the liver's main vein) without using radiation or injected dyes, making it a valuable, non-invasive option for evaluating liver disease. ^{2 6 7 8 9}

Who Is on the Research Team?

Prashant Kedia, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for individuals with liver disease who are already scheduled to have an endoscopic ultrasound-guided liver biopsy. Specific eligibility details aren't provided, but typically participants should meet certain health standards and not have conditions that could interfere with the study or their safety.

Inclusion Criteria

I have liver disease or suspected cirrhosis and am considered for a specific medical procedure.

I am referred for an EUS procedure and liver biopsy.

Exclusion Criteria

Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study

I am unable or unwilling to sign the consent form.

Endoscopic procedures are not safe for me.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo Endoscopic-Ultrasound Guided liver biopsies and Portal Pressure Gradient Measurements

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement

Trial Overview The trial is testing a procedure called Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement (EUS-PPGM) during routine liver biopsies in patients with liver disease to assess its safety and effectiveness.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Patients undergoing Endoscopic-Ultrasound Guided liver biopsies and Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurements

Who Is Running the Clinical Trial?

Methodist Health System

Lead Sponsor

Trials

156

Recruited

4,826,000+

Citations

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

Endoscopic ultrasound-guided portal pressure gradient ... Endoscopic ultrasound guided portal pressure gradient measurement in predicting outcomes of abdominal surgery in patients with chronic liver disease. United ...

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 ... Endoscopic ultrasound–guided portosystemic pressure gradient correlates with clinical parameters and liver histology.

4. 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.

5. journals.lww.com journals.lww.com/ajg/fulltext/2023/10001/s1248_a_new_frontier__endoscopic_ultrasound_guided.2066.aspx

S1248 A New Frontier: Endoscopic Ultrasound-Guided ... EUS-PPG is a safe and effective modality of diagnosing portal hypertension. With the direct measurement of pressure, no radiographic exposure, or intravenous ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12080684/

EUS-guided portal pressure gradient measurement for ... EUS-PPG measurement seems to be an effective technique for assessing disease severity and risk of variceal bleeding in patients with diagnosed cirrhosis or ...

7. journals.lww.com journals.lww.com/ajg/fulltext/2024/10001/s4071_endoscopic_ultrasound_guided_portal_pressure.4072.aspx

S4071 Endoscopic Ultrasound-Guided Portal Pressure ... The gradient post TIPS placement was 5 mmHg. Discussion: EUS-guided PPG measurement is safe and accurate for evaluating portal hypertension. While the HVPG ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/poh2.78

Endoscopic ultrasound‐guided portal pressure gradient ... Of the 18 patients, 15 underwent concurrent EUS-liver biopsy, which was 100% successful and provided diagnostic histology for all patients. The ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40689144/

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