The Use of Endoscopic Ultrasound-Guided Portal Pressure Measurements to Guide Beta-Blocker Therapy in Patients With Compensated Cirrhosis

Cirrhosis Clinical Trial

Official title:

The Use of Endoscopic Ultrasound-Guided Portal Pressure Measurements to Guide Beta-Blocker Therapy in Patients With Compensated Cirrhosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05357599
• Other study ID #: APP-22-01828
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: July 2025

Study information

• Verified date: March 2023
• Source: University of Southern California
• Contact: Jessica D Serna, BS
• Phone: 323-409-6939
• Email: Jessica.Serna[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years of age.

2. 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.

Exclusion Criteria:

1. Prior decompensation, which includes a history of variceal hemorrhage, ascites, and/or hepatic encephalopathy;

2. other complications of cirrhosis that can affect portal pressures, such as splenic or portal vein thrombosis and/or hepatocellular carcinoma,

3. use of any medications (i.e. current beta-blocker use) or prior procedure that affects splanchnic hemodynamics or portal pressure;

4. contraindications to beta-blockers, including resting heart rate <60, systolic blood pressure <90, history of bronchospasm;

5. current incarceration;

6. pregnancy; and

7. inability to give informed consent.

Related Conditions & MeSH terms

• Cirrhosis
• Compensated Cirrhosis
• Fibrosis
• Hypertension, Portal
• Liver Cirrhosis
• Portal Hypertension

Intervention

Diagnostic Test:
• EUS
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of guiding B blocker therapy for variceal screening	Feasibility will be measured by procedure success, Intra-procedure times, and adverse events.	Procedure through study completion, an average of 7 days
Secondary	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.	Baseline