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临床试验/NCT07703540
NCT07703540已完成不适用

Inferior Vena Cava Pressure as Alternative to Hepatic Venous Pressure for EUS-guided Portal Pressure Gradient Measurement

University Hospital Muenster1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

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

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

发起方
University Hospital Muenster
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Michael Praktiknjo

Professor of hepatology

University Hospital Muenster

研究点 (1)

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