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临床试验/NCT04642794
NCT04642794已完成不适用

Management of Portoplenomesenteric Vein Thrombosis in Patients With Acute Pancreatitis : an Observational Study

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
incidence of anticoagulation therapy

研究概览

简要总结

Severe acute pancreatitis (AP) is a pathology with high morbidity and mortality. Portosplenomesenteric vein thrombosis is a well-known local complication of AP with a variable incidence, which can reach up to 50% in case of severe AP. However, there is no specific recommendation regarding the management of Portosplenomesenteric vein thrombosis. By analogy to all venous thrombosis, the European Society of Gastroenterology recommends curative anticoagulation. However, the efficacy of curative anticoagulation has never been evaluated by prospective studies. In addition, bleeding complications during AP occur in approximately 10% of patients and are associated with a poor prognosis.

The investigators wish to conduct an observational multi-center study with epidemiologic aims, including all patients admitted for AP and with a diagnosis of portosplenomesenteric vein thrombosis. The aim of this study is to evaluate the therapeutic management of these patients, the efficacy and safety of anticoagulant treatment for the treatment of Portosplenomesenteric vein thrombosis, and their outcomes.

详细描述

The investigators will include prospectively all patients admitted for AP with a computed tomography diagnosis of portosplenomesenteric vein thrombosis.

研究设计

研究类型
Observational
观察模型
Other
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

  • Adult Patients (age > 18 years) with acute pancreatitis
  • AND a diagnosis on CT injected with portal time of portosplenomesenteric vein thrombosis or laminated veins (without passage of blood flow through the vessel but without visible intraluminal thrombus) will be included.

排除标准

  • Patient under guardianship
  • Refusal to participate in research
  • Pregnancy

结局指标

主要结局

incidence of anticoagulation therapy

时间窗: up to 12 months

incidence defined as : the ratio of the number of patients on curative anticoagulant therapy to the number of patients admitted with AP and portosplenomesenteric vein thrombosis during the inclusion period

次要结局

  • hospital mortality at 12 months(12 months)
  • incidence of hepatic ischemia(up to 12 months)
  • evaluate the outcomes of Number of patients admitted for AP with portosplenomesenteric vein thrombosis(up to 12 months)
  • incidence of occurrence of malabsorption(up to 12 months)
  • incidence of digestive ischemia(up to 12 months)
  • incidence of pancreatic necrosis(up to 12 months)
  • hospital mortality at 6 months(6 months)
  • incidence of portal cavernoma(up to 12 months)
  • incidence of type 2 diabetes secondary to AP(up to 12 months)
  • hospital mortality at D90(Day 90)
  • hospital mortality at D28(Day 28)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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