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临床试验/NCT07322978
NCT07322978招募中不适用

Incidence of Splanchnic Venous Thrombosis in Acute Pancreatitis and it's Correlation With Severity of Pancreatitis - a Prospective Observational Study

Asian Institute of Gastroenterology, India1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年2月27日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Primary outcome

研究概览

简要总结

Acute pancreatitis (AP) is a common medical condition characterized by inflammation of the pancreas, affecting a significant portion of the population. With approximately one-third of patients experiencing notable morbidity due to local or systemic complications, the severity of the disease is underscored by the presence of acute peripancreatic fluid collections, acute necrotic collections, pseudocysts, and walled-off necrosis1. Notably, vascular complications, such as splanchnic vein thrombosis, further contribute to the increased morbidity and mortality associated with acute pancreatitis2. Splanchnic vein thrombosis encompasses thromboses in the splenic (SpVT), portal (PVT), and superior mesenteric veins (SMVT), either individually or in combination3. These complications are often incidentally discovered during imaging procedures conducted to assess potential complications4. Despite most cases being asymptomatic, fatal complications, including bowel ischemia, liver failure, portal hypertension, and life-threatening bleeding, have been documented, with the risk of splanchnic vein thrombosis escalating with the severity of pancreatitis

详细描述

Acute pancreatitis (AP) is a common medical condition characterized by inflammation of the pancreas, affecting a significant portion of the population. With approximately one-third of patients experiencing notable morbidity due to local or systemic complications, the severity of the disease is underscored by the presence of acute peripancreatic fluid collections, acute necrotic collections, pseudocysts, and walled-off necrosis1. Notably, vascular complications, such as splanchnic vein thrombosis, further contribute to the increased morbidity and mortality associated with acute pancreatitis2. Splanchnic vein thrombosis encompasses thromboses in the splenic (SpVT), portal (PVT), and superior mesenteric veins (SMVT), either individually or in combination3. These complications are often incidentally discovered during imaging procedures conducted to assess potential complications4. Despite most cases being asymptomatic, fatal complications, including bowel ischemia, liver failure, portal hypertension, and life-threatening bleeding, have been documented, with the risk of splanchnic vein thrombosis escalating with the severity of pancreatitis.

The intricate relationship between the pancreas and large mesenteric vessels, coupled with systemic inflammatory responses, hypovolemia, fluid shifts, and prothrombotic states, contributes to the development of splanchnic vein thrombosis in acute pancreatitis5. Early detection of these thrombotic events becomes imperative to mitigate long-term sequelae such as portal hypertension and chronic mesenteric ischemia6. Despite the critical importance of identifying splanchnic vein thrombosis in acute pancreatitis, there is a notable absence of standardized recommendations for initiating anticoagulation treatment in these cases5. The decision-making process is further complicated by the potential risk of bleeding associated with other vascular complications, such as bleeding into pseudocysts or pseudo-aneurysmal bleeds7. As a result, there is a pressing need for more comprehensive studies that delve into the risk factors, pathogenesis, therapeutic impacts, and outcome predictors associated with splanchnic vein thrombosis in the context of acute pancreatitis. These investigations will not only enhance our understanding of the condition but also inform the development of evidence-based guidelines for the management of splanchnic vein thrombosis in individuals with acute pancreatitis.

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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18-85 years of age.
  • Diagnosis of AP as per international consensus criteria.

排除标准

  • Chronic pancreatitis.
  • Established malignancy.
  • Cirrhosis of liver or established portal hypertension.
  • Pregnancy.

结局指标

主要结局

Primary outcome

时间窗: 1 year

Detection of thrombus in splenic, superior mesenteric or portal vein.

次要结局

  • Secondary Outcome(6 months)
  • Secondary Outcome(1 year)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Sponsor

研究点 (1)

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