Clinical trial NCT05357599: The Use of Endoscopic Ultrasound-Guided Portal Pressure Measurements to Guide Beta-Blocker Therapy in Patients With Compensated Cirrhosis
Official title: The Use of Endoscopic Ultrasound-Guided Portal Pressure Measurements to Guide Beta-Blocker Therapy in Patients With Compensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cirrhosis
Compensated Cirrhosis
Portal Hypertension
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of guiding B blocker therapy for variceal screening
timeFrame: Procedure through study completion, an average of 7 days
Secondary outcomes:
measure: Initiation on beta-blocker therapy based EGD alone versus EGD+EUS-PPG.
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: LAC+USC Medical Center
name: James Buxbaum, MD
role: PRINCIPAL_INVESTIGATOR
References: