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

NCT05357599 | Unknown

• 1 other identifier: APP-22-01828
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Cirrhosis; Compensated Cirrhosis; Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Initiation on beta-blocker therapy based EGD alone versus EGD+EUS-PPG.

  Baseline

Study Arms (1)

Beta Blocker at EUS

EXPERIMENTAL

Diagnostic Test: EUS

Interventions

EUS DIAGNOSTIC_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)

Beta Blocker at EUS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

MeSH Terms

Conditions

Fibrosis; Hypertension, Portal

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• James Buxbaum, MD

  LAC+USC Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica D Serna, BS

CONTACT

323-409-6939; Jessica.Serna@med.usc.edu

Alex Rodriguez, BS

CONTACT

323-409-6939; Alex.Rodriguez@med.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology Los Angeles County + University of Southern California

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: May 3, 2022
• Study Start: December 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 6, 2023

Record last verified: 2023-03