CirrhosisNCT05357599
The Use of Endoscopic Ultrasound-Guided Portal Pressure Measurements to Guide Beta-Blocker Therapy in Patients With Compensated Cirrhosis
A study testing EUS in people with Cirrhosis and Compensated Cirrhosis, run by University of Southern California.
Trial summary
This pilot study to determine the feasibility of EUS-Portal Pressure Measurements to guide Beta-Blocker Therapy in patients with compensated cirrhosis .The study will be a prospective tandem controlled trial consisting of 30 patients who are already undergoing routine endoscopy screening for portal hypertension as… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Compensated Cirrhosis, Portal Hypertension
- What is being tested?
- EUS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Jul 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years of age.
- diagnosis of Child-Pugh class A cirrhosis who present to LAC+USC for variceal screening.
- A diagnosis of cirrhosis will be determined histologically based on biopsy alone or clinically by reviewing notes from a gastroenterology or hepatology provider with imaging and clinical history consistent with cirrhosis.
Who cannot join
- Prior decompensation, which includes a history of variceal hemorrhage, ascites, and/or hepatic encephalopathy;
- other complications of cirrhosis that can affect portal pressures, such as splenic or portal vein thrombosis and/or hepatocellular carcinoma,
- use of any medications (i.e. current beta-blocker use) or prior procedure that affects splanchnic hemodynamics or portal pressure;
- contraindications to beta-blockers, including resting heart rate <60, systolic blood pressure <90, history of bronchospasm;
- current incarceration;
- pregnancy; and
- inability to give informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
This pilot study to determine the feasibility of EUS-Portal Pressure Measurements to guide Beta-Blocker Therapy in patients with compensated cirrhosis .The study will be a prospective tandem controlled trial consisting of 30 patients who are already undergoing routine endoscopy screening for portal hypertension as part of their routine clinical care . The decision to start a beta-blocker will be made at the conclusion of the EGD based on the endoscopic findings (presence of esophageal varices). EUS-PPG will then be performed and measurements will be collected. The primary outcome is the feasibility of guiding B blocker therapy by EGD+EUS-PPG at the time of EGD for variceal screening. The secondary outcome will be the proportion of patients initiated on beta-blocker therapy based on EGD alone versus EGD+EUS-PPG
Read the detailed description
The study will be a prospective tandem controlled trial consisting of 30 patients who are undergoing EGD followed by EUS-PPG at Los Angeles County + University of Southern California Medical Center (LAC+USC).
Only patients undergoing endoscopic screening for portal hypertension as part of routine clinical care will be considered for the study.
All procedures will be performed with the patient under moderate sedation or monitored anesthesia care as is standard in our endoscopy unit. EGD with a forward-viewing scope will be performed initially in all patients to evaluate and document the presence of esophageal varices. Any other endoscopic evidence of portal hypertension, such as portal hypertensive gastropathy or gastric varices, will also be documented.
The decision to start a beta-blocker will be made at the conclusion of the EGD based on the endoscopic findings (presence of any esophageal varices).
EUS-PPG will then be performed. Using the dedicated 25-gauge portal systemic pressure measurement needle, the hepatic venous system and portal venous system will be directly accessed to allow measurements. The mean portal pressure gradient will be recorded. We will then record whether beta-blockers would be initiated based on portal pressure measurements ≥10mmHg.
The peri-procedure management will be performed according to standard of care within our endoscopy unit. As is our standard clinical care for patients with portal hypertension, for patients found to have evidence of portal hypertension we will start the beta-blocker carvedilol 6.25mg twice a day will be started on the day following the procedure. If tolerated, the dose will be increased to 12.5mg twice a day after one month.
The patients will be blinded to whether or not the decision to start beta-blockers was based on EGD, EUS-PPG or both findings. The patient will be followed clinically by the principal investigator assisted by a full time study coordinator and team with extensive prospective clinical trials experience
- Conditions
- Cirrhosis, Compensated Cirrhosis, Portal Hypertension
- Being tested
- EUS
- Medical subject headings
- Fibrosis, Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUSDiagnostic test
The decision to start a beta-blocker will be made at the conclusion of the EGD based on the endoscopic findings (presence of esophageal varices)
| Study group | Role | What they receive |
|---|---|---|
| Beta Blocker at EUS | Experimental | Not described Receives: Diagnostic Test: EUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of guiding B blocker therapy for variceal screening
Feasibility will be measured by procedure success, Intra-procedure times, and adverse events.
Measured: Procedure through study completion, an average of 7 days
Secondary outcomes (1)
Initiation on beta-blocker therapy based EGD alone versus EGD+EUS-PPG.
The secondary outcome will be the proportion of patients initiated on beta-blocker therapy based on EGD alone versus EGD+EUS-PPG.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study startDec 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Buxbaum, University of Southern California
- Investigators
- James Buxbaum, MD, Principal investigator, LAC+USC Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357599
- Sponsor's protocol ID
- APP-22-01828
- Status last verified
- Mar 2023
- First submitted
- 17 Apr 2022
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Endoscopic Ultrasound-Guided Portal Pressure Measurements to Guide Beta-Blocker Therapy in Patients With Compensated Cirrhosis
- ClinicalTrials.gov ID
- NCT05357599
- Acronym / sponsor ID
- APP-22-01828
- Conditions
- Cirrhosis, Compensated Cirrhosis, Portal Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 3 May 2022 (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.
This pilot study to determine the feasibility of EUS-Portal Pressure Measurements to guide Beta-Blocker Therapy in patients with compensated cirrhosis .The study will be a prospective tandem controlled trial consisting of 30 patients who are already undergoing routine endoscopy screening for portal hypertension as part of their routine clinical care . The decision to start a beta-blocker will be made at the conclusion of the EGD based on the endoscopic findings (presence of esophageal varices). EUS-PPG will then be performed and measurements will be collected. The primary outcome is the feasibility of guiding B blocker therapy by EGD+EUS-PPG at the time of EGD for variceal screening. The secondary outcome will be the proportion of patients initiated on beta-blocker therapy based on EGD alone versus EGD+EUS-PPG
Detailed description
The study will be a prospective tandem controlled trial consisting of 30 patients who are undergoing EGD followed by EUS-PPG at Los Angeles County + University of Southern California Medical Center (LAC+USC).
Only patients undergoing endoscopic screening for portal hypertension as part of routine clinical care will be considered for the study.
All procedures will be performed with the patient under moderate sedation or monitored anesthesia care as is standard in our endoscopy unit. EGD with a forward-viewing scope will be performed initially in all patients to evaluate and document the presence of esophageal varices. Any other endoscopic evidence of portal hypertension, such as portal hypertensive gastropathy or gastric varices, will also be documented.
The decision to start a beta-blocker will be made at the conclusion of the EGD based on the endoscopic findings (presence of any esophageal varices).
EUS-PPG will then be performed. Using the dedicated 25-gauge portal systemic pressure measurement needle, the hepatic venous system and portal venous system will be directly accessed to allow measurements. The mean portal pressure gradient will be recorded. We will then record whether beta-blockers would be initiated based on portal pressure measurements ≥10mmHg.
The peri-procedure management will be performed according to standard of care within our endoscopy unit. As is our standard clinical care for patients with portal hypertension, for patients found to have evidence of portal hypertension we will start the beta-blocker carvedilol 6.25mg twice a day will be started on the day following the procedure. If tolerated, the dose will be increased to 12.5mg twice a day after one month.
The patients will be blinded to whether or not the decision to start beta-blockers was based on EGD, EUS-PPG or both findings. The patient will be followed clinically by the principal investigator assisted by a full time study coordinator and team with extensive prospective clinical trials experience
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beta Blocker at EUS | Experimental | Diagnostic Test: EUS |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-75 years of age.
- diagnosis of Child-Pugh class A cirrhosis who present to LAC+USC for variceal screening.
- A diagnosis of cirrhosis will be determined histologically based on biopsy alone or clinically by reviewing notes from a gastroenterology or hepatology provider with imaging and clinical history consistent with cirrhosis.
Key exclusion criteria (7 listed)
- Prior decompensation, which includes a history of variceal hemorrhage, ascites, and/or hepatic encephalopathy;
- other complications of cirrhosis that can affect portal pressures, such as splenic or portal vein thrombosis and/or hepatocellular carcinoma,
- use of any medications (i.e. current beta-blocker use) or prior procedure that affects splanchnic hemodynamics or portal pressure;
- contraindications to beta-blockers, including resting heart rate <60, systolic blood pressure <90, history of bronchospasm;
- current incarceration;
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 |
|---|---|---|
| EUSThe decision to start a beta-blocker will be made at the conclusion of the EGD based on the endoscopic findings (presence of esophageal varices) | Diagnostic test | Beta Blocker at EUS |
Primary outcome
Feasibility of guiding B blocker therapy for variceal screening
Time frame: Procedure through study completion, an average of 7 days
Feasibility will be measured by procedure success, Intra-procedure times, and adverse events.
1 secondary outcome
Initiation on beta-blocker therapy based EGD alone versus EGD+EUS-PPG.
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
James Buxbaum, MD principal investigator
LAC+USC Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing EUS in people with Cirrhosis and Compensated Cirrhosis, run by University of Southern California.
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 7 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: status not confirmed, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica D Serna, BS (323-409-6939, Jessica.Serna@med.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of guiding B blocker therapy for variceal screening (time frame: Procedure through study completion, an average of 7 days). 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 6 Mar 2023.