Registry of Patients Undergoing Endoscopic Management of Pancreatic Fluid Collections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.
研究概览
简要总结
Acute pancreatitis is one of the most common gastrointestinal disorders requiring hospitalization worldwide. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.
Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.
详细描述
Acute pancreatitis has an annual incidence of 13-45 cases per 100,000 persons and is one of the most common gastrointestinal disorders requiring hospitalization worldwide. It leads to over a quarter of a million hospital admissions annually in the United States, and inpatient costs exceeding 2.5 billion US dollars. Pancreatic fluid collections can occur as a consequence of acute and chronic pancreatitis and can result in significant morbidity and mortality, including significant abdominal pain, gastric outlet obstruction, biliary obstruction, organ failure, persistent unwellness, infection and sepsis.
Symptomatic pancreatic fluid collections require treatment, and endoscopic drainage is considered standard of care. Endoscopic treatment involves the drainage of the fluid collection into the stomach or duodenum by placement of metal or plastic stents. If clinically indicated, endoscopic necrosectomy is also performed, which is the removal of devitalized pancreatic tissue using the endoscope. Currently the treatment success rate of endoscopic treatment of pancreatic fluid collections exceeds 90%.
The aim of this study is to evaluate the treatment outcomes in patients undergoing standard of care, endoscopic treatment of pancreatic fluid collections.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Age ≥ 18 years
- •All patients undergoing endoscopic treatment of pancreatic fluid collections
排除标准
- •Age < 18 years
- •Patients who did not receive endoscopic treatment of pancreatic fluid collections
结局指标
主要结局
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.
时间窗: 3 years
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections.
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections according to timing of treatment.
时间窗: 6 months
Treatment outcomes in patients undergoing endoscopic treatment of pancreatic fluid collections is assessed as a composite measure consisting of 1) adverse events or 2) need for hospital admission due to underlying disease or procedure-related adverse events, in patients undergoing endoscopic treatment of pancreatic fluid collections, according to timing of treatment.
次要结局
- Treatment success(6 months)
- Number and type of interventions performed(6 months)
- Need for surgical intervention(6 months)
- Technical success of endoscopic interventions in pancreatic fluid collections.(6 months)
- Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.(6 months)
- Disease-related adverse events(6 monthts)
- Procedure-related adverse events(6 months)
- Hospital admission(6 months)
- Timing of intervention(6 months)
- Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome(6 months)
- Disease recurrence(6 months)
- Diabetes(6 months)
- Exocrine pancreatic insufficiency(6 months)
- Treatment costs(6 months)
- Treatment success(6 months)
- Number and type of interventions performed(6 months)
- Need for surgical intervention(6 months)
- Technical success of endoscopic interventions in pancreatic fluid collections.(6 months)
- Inflammatory response and organ failure in patients undergoing endoscopic therapy for pancreatic fluid collections.(6 months)
- Disease-related adverse events(6 monthts)
- Procedure-related adverse events(6 months)
- Timing of intervention(6 months)
- Hounsfield units of the pancreatic fluid collection(6 months)
- Impact of partial versus full encapsulation of pancreatic fluid collections(6 months)
- Incidence of disconnected pancreatic duct syndrome and sequelae of disconnected pancreatic duct syndrome(3 years)
- Hospital admission(6 months)
- Disease recurrence(3 years)
- Diabetes(3 years)
- Exocrine pancreatic insufficiency(3 years)