The Use of Endoscopic Ultrasound-Guided Portal Pressure Measurements to Guide Beta-Blocker Therapy in Patients With Compensated Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Feasibility of guiding B blocker therapy for variceal screening
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Feasibility of guiding B blocker therapy for variceal screening
时间窗: Procedure through study completion, an average of 7 days
Feasibility will be measured by procedure success, Intra-procedure times, and adverse events.
次要结局
- Initiation on beta-blocker therapy based EGD alone versus EGD+EUS-PPG.(Baseline)
研究者
James Buxbaum
Chief of Gastroenterology Los Angeles County + University of Southern California
University of Southern California