Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- EUS-guided response assessment to NSBB in the treatment of CSPH.
研究概览
简要总结
The goal of this clinical trial is to learn if endoscopic ultrasound (EUS)-guided portal pressure measurement can determine the treatment response to non-selective beta-blockers (NSBB) in patients with cirrhosis and clinically significant portal hypertension (CSPH). Participants will undergo EUS-guided portal pressure measurement before start of Carvedilol en after three months of treatment. EUS-guided measurements will be paired with transjugular hepatic venous pressure gradient (HVPG) measurement as well as non-invasive tests for assessment of portal hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical and/or pathological diagnosis of compensated cirrhosis.
- •Patients with suspicion of CSPH and thus indication for NSBB treatment.
- •Patients not yet on NSBB therapy.
- •Patients willing and able to undergo repeated HVPG and EUS-guided pressure measurements as per protocol.
排除标准
- •General criteria
- •Patient is <18 or >80 years of age
- •Patient is pregnant, breast-feeding or planning to become pregnant during the course of the study
- •Patient is unwilling or unable to sign the informed consent
- •Patients in whom general anesthesia or endoscopic procedures are contraindicated Medical criteria
- •Patients with cirrhosis and HCC Portopulmonary hypertension Portal or splanchnic venous thrombosis Prior TIPS Prior liver transplantation
- •Non-cirrhotic portal hypertension or pre-sinusoidal liver disease
- •Cholestatic liver disease with total bilirubin >3 mg/dl
- •Previous total or partial splenectomy
- •Known infection that is not controlled by medical intervention
- •Patients with contraindications for non-selective beta-blocker therapy, including but not limited to the following baseline vital signs:
- •Systolic BP <100 mmHg HR <50 bpm
- •Patients with reduced life expectancy described by an ASA score of 4 or 5
- •INR >1.7 or platelet count <50.000 per mm3
- •eGFR <50 ml/min/1.73m2 (CKD-EPI formula) Anatomical criteria
- •Anatomical abnormalities that prevent access via EUS-guided puncture to the hepatic vein or intrahepatic portion of the portal vein, including anatomy that predisposes to difficult to reach puncture sites or an inadequate needle angle.
- •Visualization of ascites interposing the puncture tract on EUS
- •Diagnosis of portal vein thrombosis during EUS
- •Evidence of active gastrointestinal bleeding during EUS
研究组 & 干预措施
EUS-PPG before and after NSBB
Patients will undergo EUS-PPG and HVPG before and after NSBB treatment and will thus serve as their own control.
干预措施: endoscopic ultrasound-guided portal pressure measurement (Procedure)
结局指标
主要结局
EUS-guided response assessment to NSBB in the treatment of CSPH.
时间窗: Three months
To assess if a positive response to non-selective beta-blockers (NSBB) treatment, as determined by a reduction of 10% or more in the hepatic venous pressure gradient (HVPG) and/or a decrease to values less than 12 mmHg, can be similarly observed using endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement.
次要结局
- Correlation of PVP with WHVP.(Three months)
- Correlation of EUS-PPG with HVPG(Three months)
- CSPH assessed via EUS-guided pressure measurement.(Three months)
- Safety of repeated EUS-PPG(14 weeks)
- Correlation of FHVP with HVP.(Three months)
- Correlation of sequential EUS-PPG and HVPG with non-invasive assessment tools before/after treatment with NSBB.(Three months)