Inferior Vena Cava Pressure as Alternative to Hepatic Venous Pressure for EUS-guided Portal Pressure Gradient Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Agreement between mean hepatic vein pressure and mean inferior vena cava pressure measured during the same EUS-PPG session
研究概览
简要总结
This study investigates a new, simplified approach to measuring blood pressure within the liver (portal hypertension) using Endoscopic Ultrasound-Guided Portal Pressure Gradient Measurement (EUS-PPG). While this minimally invasive method traditionally relies on a hepatic vein as the baseline reference point, advanced liver scarring can make these veins twisted and highly difficult to access. To address this challenge, our study evaluates the Inferior Vena Cava (IVC)-the body's largest main vein-as an alternative reference site. Currently, it remains scientifically unproven whether the inferior vena cava or the hepatic vein provides the more reliable and accurate pressure reading for calculation, as anatomical distortion from cirrhosis can affect both areas differently. By measuring and comparing both venous compartments during a single, clinically scheduled endoscopy session, this study aims to determine if the pressures are truly interchangeable. Ultimately, this research will clarify which vessel serves as the optimal reference point, helping to establish a safer, more reliable diagnostic standard for patients with complex vascular anatomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive adult patients (≥18 years) undergoing clinically indicated EUS-guided portal pressure gradient measurement
排除标准
- •severe coagulopathy (INR >2.0), thrombocytopenia (<50,000/µL)
- •large-volume ascites
- •gastric varices precluding safe vascular puncture
- •known hepatic vein thrombosis or Budd-Chiari syndrome
- •altered IVC anatomy such as patients after liver transplantation with piggy-back anastomosis
- •contraindication to upper gastrointestinal endoscopy or sedation
- •pregnancy
研究组 & 干预措施
HVP-PPG and IVCP-PPG
Patients undergoing both measurements (HVP-PPG and IVCP-PPG)
干预措施: HVP-PPG and IVCP-PPG (Diagnostic Test)
结局指标
主要结局
Agreement between mean hepatic vein pressure and mean inferior vena cava pressure measured during the same EUS-PPG session
时间窗: Intraprocedural
Based on prior reproducibility data for EUS-guided portal pressure measurements, a predefined absolute difference of \>1 mmHg between HVP and IVCP was considered clinically relevant. Differences ≤1 mmHg after rounding to the nearest whole mmHg were considered hemodynamically equivalent, reflecting clinical pressure reporting practice.
次要结局
- Correlation between HVP and IVCP, Bland-Altman analysis of agreement and systematic bias(Intraprocedural measurement)
- Agreement between PPG-HV and PPG-IVC(Intraprocedural measurement)
- Reclassification across clinically significant portal hypertension thresholds (≥10 mmHg)(Intraprocedural measurement)
- Intraprocedural variability of triplicate measurements(Intraprocedural measurement)
- Procedural adverse events(Up to 72 hours)
研究者
Prof. Dr. Michael Praktiknjo
Professor of hepatology
University Hospital Muenster
