Liver DiseasesNCT06336850
Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
A study testing Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement in people with Liver Diseases, run by Methodist Health System at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2020to 17 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Patient who has been referred for EUS procedure and direct PPG measurement and -undergoing EUS-guided liver biopsy
- History of liver disease or suspected cirrhosis and considered for PPGM
Who cannot join
- Patient is less than 18 or greater than 85 years of age
- Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
- Patient is unwilling or unable to sign and date the informed consent
- Patient for whom endoscopic procedures are contraindicated.
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies.
Read the detailed description
Patients undergoing EUS-guided liver biopsy may qualify to participate in this study. The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS- Portal Pressure Gradient Measurement (PPGM) in patients with liver disease referred for EUS-guided liver biopsy.
- Conditions
- Liver Diseases
- Being tested
- Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound-Guided Portal Pressure Gradient MeasurementProcedure or surgery
The endoscopic ultrasound (EUS)-guided 25G fine needle aspirate (FNA) needle procedure is a straightforward minimally invasive technique for direct portal pressure measurements.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients undergoing Endoscopic-Ultrasound Guided liver biopsies and Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurements Receives: Procedure: Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portal Pressure Gradient Measurements from Hepatic and Portal Veins
A catheter is inserted into the hepatic vein before hepatic venous pressure and portal vein pressure are recorded
Measured: 2 years
Secondary outcomes (2)
Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension
Statistical tests to determine relationship between portal pressure gradient measurements and portal hypertension
Measured: 2 years
Clinical significance between portal pressure gradient measurement and portal hypertension
Presence of varices, hypertensive gastropathy, or thrombocytopenia.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start23 Dec 2020
- Primary completion17 Oct 2023
- Study completion17 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prashant Kedia, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336850
- Sponsor's protocol ID
- 069.GID.2020.D
- Status last verified
- Jun 2026
- First submitted
- 9 Dec 2021
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement
- ClinicalTrials.gov ID
- NCT06336850
- Acronym / sponsor ID
- 069.GID.2020.D
- Conditions
- Liver Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 17 Oct 2023 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety, and adequacy of Endoscopic Ultrasound (EUS) Portal Pressure Gradient Measurement (PPGM) in patients undergoing EUS-guided liver biopsies.
Detailed description
Patients undergoing EUS-guided liver biopsy may qualify to participate in this study. The purpose of this study is to evaluate the efficacy, safety, and adequacy of EUS- Portal Pressure Gradient Measurement (PPGM) in patients with liver disease referred for EUS-guided liver biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: Endoscopic Ultrasound-Guided Portal Pressure Gradient MeasurementPatients undergoing Endoscopic-Ultrasound Guided liver biopsies and Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurements |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Patient who has been referred for EUS procedure and direct PPG measurement and -undergoing EUS-guided liver biopsy
- History of liver disease or suspected cirrhosis and considered for PPGM
Key exclusion criteria (4 listed)
- Patient is less than 18 or greater than 85 years of age
- Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study
- Patient is unwilling or unable to sign and date the informed consent
- Patient for whom endoscopic procedures are contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Ultrasound-Guided Portal Pressure Gradient MeasurementThe endoscopic ultrasound (EUS)-guided 25G fine needle aspirate (FNA) needle procedure is a straightforward minimally invasive technique for direct portal pressure measurements. | Procedure or surgery | Treatment |
Primary outcome
Portal Pressure Gradient Measurements from Hepatic and Portal Veins
Time frame: 2 years
A catheter is inserted into the hepatic vein before hepatic venous pressure and portal vein pressure are recorded
2 secondary outcomes
Correlation between Portal Pressure Gradient Measurements and the presence or absence of portal hypertension
Time frame: 2 years
Clinical significance between portal pressure gradient measurement and portal hypertension
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prashant Kedia, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement in people with Liver Diseases, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portal Pressure Gradient Measurements from Hepatic and Portal Veins (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.