Diagnostic Role of the Hepatic Venous Pressure Gradient and Elastography in Porto-sinusoidal Vascular Disorder With Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Liver biopsy major findings
研究概览
简要总结
Porto-sinusoidal vascular disorder (PSVD) is considered a rare cause of portal hypertension (PH), resulting from specific histological alterations that essentially affect the small portal branches and sinusoids, in the absence of cirrhosis.
In recent years, the recognition and importance of PSVD has increased, notably due to the widespread use of transient elastography (TE). However, the definitive diagnosis of PSVD can only be established through liver biopsy. Recent data show that PSVD should be suspected in patients with PH and TE ≤ 20 kPa and liver biopsy should be considered in this context.
The investigators hypothesize that hepatic venous pressure gradient (HVPG) and magnetic resonance liver elastography (MRE) may help in the selection of liver biopsy candidates for the diagnosis of PSVD.
The primary objective of the study is to describe HVPG and MRE values and liver biopsy findings in patients with PH and TE ≤ 20 kPa. The search for serum markers that can distinguish these patients from those with cirrhotic portal hypertension without the need for liver biopsy will also be the object of this study.
50 patients will be included, prospectively and retrospectively, in a comparative study between diagnostic methods, with a cross-sectional design.
详细描述
Porto-sinusoidal vascular disorder (PSVD) is considered a rare cause of portal hypertension (PH), resulting from specific histological alterations that essentially affect the small portal branches and sinusoids, in the absence of cirrhosis.
In recent years, the recognition and importance of PSVD has increased, notably due to the widespread use of transient elastography (TE). However, the definitive diagnosis of PSVD can only be established through liver biopsy. Recent data show that PSVD should be suspected in patients with PH and TE ≤ 20 kPa and liver biopsy should be considered in this context.
The investigators hypothesize that hepatic venous pressure gradient (HVPG) and magnetic resonance liver elastography (MRE) may help in the selection of liver biopsy candidates for the diagnosis of PSVD.
Primary objectives are:
- To describe the measurement of the hepatic venous pressure gradient (in mmHg) in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa.
- To describe hepatic (in kPa) and splenic (in kPa) stiffness measured by magnetic resonance elastography in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa.
- To describe the frequency of major histological findings for the diagnosis of portal sinusoidal vascular disorder (obliterative portal venopathy, regenerative nodular hyperplasia and incomplete septal cirrhosis) in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa.
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
- •Age ≥ 18 years;
- •Patients with specific signs of portal hypertension:
- •Endoscopic: esophagogastric/ectopic varices;
- •On imaging (US, CT or MRI): portosystemic collateral veins;
- •Transient hepatic elastography with valid values ≤ 20 kPa;
- •Signed written informed consent form.
排除标准
- •Contraindications to HVPG or percutaneous liver biopsy:
- •Allergy to iodine
- •Chronic kidney disease with creatinine clearance < 50 ml/min
- •Anticoagulation
- •Platelets < 50,000/mm3
- •Confounding factors:
- •Hepatitis C treated with SVR
- •Conditions that exclude the diagnosis of PSVD:
- •History of bone marrow transplant
- •Budd-Chiari
- •Congestive heart failure or Fontan surgery
- •Abernethy's Syndrome
- •Hereditary hemorrhagic telangiectasia
- •Chronic cholestatic diseases
- •Neoplastic hepatic infiltration
- •Sarcoidosis
- •Congenital hepatic fibrosis
- •Hepatosplenic schistosomiasis
- •Portal cavernoma / thrombosis with complete occlusion of the main portal vein.
结局指标
主要结局
Liver biopsy major findings
时间窗: 12 months
To describe the frequency of major histological findings for the diagnosis of portal sinusoidal vascular disorder (obliterative portal venopathy, regenerative nodular hyperplasia and incomplete septal cirrhosis) in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa.
Hepatic venous pressure gradient measurement
时间窗: 12 months
To describe the measurement of the hepatic venous pressure gradient (in mmHg) in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa.
Magnetic resonance elastography
时间窗: 12 months
To describe hepatic (in kPa) and splenic (in kPa) stiffness measured by magnetic resonance elastography in patients with portal hypertension and transient hepatic elastography ≤ 20 kPa.
次要结局
- Non-invasive markers - procollagen III amino-terminal peptide(12 months)
- Hepatic vein-to-vein communications(12 months)
- Liver biopsy minor findings(12 months)
- Non-invasive markers - von Willebrand antigen factor(12 months)
- Non-invasive markers - anti-endothelial cell antibodies(12 months)
研究者
Guilherme Rezende
Associate Professor
Universidade Federal do Rio de Janeiro