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New treatment option for Portal Hypertension
Official title EUS-guided Portal Pressure Gradient (PPG) Measurement: a Potential Alternative to the Traditional HVPG
ClinicalTrials.gov ID: NCT06863012
What this study is testing
- What it's testing
- The goal of this investigator-initiated, single-arm, prospective study is to evaluate the accuracy, safety, and feasibility of endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement as a potential alternative to the traditional hepatic venous pressure gradient (HVPG) method in patients with portal hypertension due to chronic liver disease. The main questions it aims to answer are: What is the correlation between EUS-PPG and HVPG measurements in patients with portal hypertension due to cirrhosis?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- people must be 18 to 85 years of age inclusive, at the time of signing the informed consent form.
- people who have a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
- people capable of giving signed informed consent.
You likely can't join if
- Pregnancy.
- Significant bleeding risk (International Normalized Ratio (INR) \> 1.5 OR platelet count \< 50000).
- Presence of active gastrointestinal bleeding at the time of screening
- History of any blood thinner consumption (e.g. warfarin, heparin, novel roal anticoagulants) within the last 5 days.
- Presence of massive ascites causing abdominal distension or requiring frequent therapeutic paracentesis.
- people having received previous Transjugular Intrahepatic Portosystemic Shunt (TIPS) or Surgical Portosystemic Shunt.
See the full eligibility criteria
- people must be 18 to 85 years of age inclusive, at the time of signing the informed consent form.
- people who have a history of liver disease and portal hypertension or suspected cirrhosis requiring HVPG measurement.
- people capable of giving signed informed consent.
- Pregnancy.
- Significant bleeding risk (International Normalized Ratio (INR) \> 1.5 OR platelet count \< 50000).
- Presence of active gastrointestinal bleeding at the time of screening
- History of any blood thinner consumption (e.g. warfarin, heparin, novel roal anticoagulants) within the last 5 days.
- Presence of massive ascites causing abdominal distension or requiring frequent therapeutic paracentesis.
- people having received previous Transjugular Intrahepatic Portosystemic Shunt (TIPS) or Surgical Portosystemic Shunt.
- Hepatocellular carcinoma not meeting Milan Criteria.
- Presence of portal vein thrombosis or another suspected component of presinusoidal portal hypertension.
- Presence of extra-hepatic cancer, terminal disease, or severe comorbidities significantly limiting life expectancy or affecting study participation.
- Stenosis or surgical anatomical alterations of the gastrointestinal tract that could preclude endoscopic access with the echoendoscope.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.