NL-OMON56366撤回不适用
Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements vs. Transjugular Balloon Occlusion Measurement: A Multicenter EU Study - ENCOUNTER (EU)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients with cirrhosis who have been referred for a procedure where HVPG is
排除标准
- •General criteria:
- •1. Patient is < 18 or > 85 years of age
- •2. Patient is pregnant, breast-feeding, or planning to become pregnant during
- •course of the study
- •3. Patient is unwilling or unable to sign and date the informed consent
- •4. Patient is unwilling to comply with the follow-up study schedule
- •5. Patient for whom endoscopic procedures are contraindicated
- •6. Patients for whom propofol general anesthesia is contraindicated
- •Medical criteria:
- •7. Platelet count <50,000 per mm3
- •8. International normalized ratio (INR) > 1.7
- •9. Estimated glomerular filtration rate (eGFR) (see Definitions section) < 50
- •mL/min/1.73m2
- •10. Previous transjugular intrahepatic or surgical portosystemic shunt
- •11. Previous total or partial splenectomy
- •12. Non-cirrhotic portal hypertension
- •13. Known history of spontaneous bacterial peritonitis (SBP) within the last
- •three months irrespective of treatment for SBP
- •14. Patients with known infection which is not controlled by medical
- •intervention
- •15. Portopulmonary hypertension
- •16. Cardiac decompensation
- •17. Pre-sinusoidal liver disease
- •18. Cholestatic liver disease
- •19. Patient who received endoscopic treatment for upper gastrointestinal (GI)
- •variceal bleeding within the past 7 days
- •20. Patients with current hepatocellular carcinoma (HCC)
- •Anatomical (identified at screening and/or during the endoscopic procedure)
- •21. Portal vein thrombosis
- •22. Anatomic abnormalities of the hepatic vasculature that prevent access to
- •the intrahepatic
- •portion of the portal vein or hepatic veins
- •23. Evidence of active GI bleeding
- •24. If the volume of ascites in the path of the needle prevents apposition of
- •the gastrointestinal
- •tract and liver
研究者
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