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临床试验/NCT01816256
NCT01816256已完成不适用

Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms

University Health Network, Toronto4 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
4
主要终点
Incidence of asymptomatic portal vein thrombosis (PVT) and/or portal hypertension (PHTN) in patients with Philadelphia negative myeloproliferative neoplasms (MPNs)

研究概览

简要总结

This study involves screening for portal vein thrombosis and portal hypertension in patients with Philadelphia negative myeloproliferative neoplasms (MPNs). These include polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis.

Portal vein thrombosis and portal hypertension are serious complications that are often seen in myeloproliferative patients. These complications are usually diagnosed when patients become symptomatic, and are often already at an advanced stage. They can further progress to cause non-reversible damage to the liver, also called cirrhosis of the liver. As a result of this, patients often accumulate fluid in the abdomen which is ascites; and can develop swelling of veins in the lining of the esophagus known as varices. If untreated, varices have the risk of rupturing resulting in life-threatening bleeding. When diagnosed at an advanced stage, the treatment is usually supportive therapy and there are no treatments available at present which can reverse these conditions.

This study is looking at screening for these two conditions using Doppler ultrasound and upper gastrointestinal endoscopy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • One of the three classical Philadelphia negative myeloproliferative neoplasms (polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)) diagnosed according to WHO or International working group-Myelofibrosis research and treatment (IWG-MRT) criteria
  • Palpable spleen length greater than 5 cm below the costal margin in MF (including primary MF or post-polycythemia vera MF (PPV-MF) post-polycythemia vera ET (PPV-ET)) or palpable spleen of any size in patients with PV or ET.
  • Ability to understand and willing to sign a written consent form.
  • Age 18 years or older at time of consent.
  • Exclusion criteria:
  • Known history of portal vein thrombosis
  • Known history of Budd-chairi syndrome
  • Known history of oesophageal varices
  • Known history of cirrhosis from any cause
  • Known history of active bleeding

排除标准

  • 未提供

结局指标

主要结局

Incidence of asymptomatic portal vein thrombosis (PVT) and/or portal hypertension (PHTN) in patients with Philadelphia negative myeloproliferative neoplasms (MPNs)

时间窗: 6 years

次要结局

  • Identify the patient, disease and treatment related risk factors associated with PVT and PHTN(6 years)
  • Comparison of survival and number of patients with leukemic transformation in patients with or without asymptomatic PVT/PHTN(8 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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