Drainage and Debridement of Local Complications of Acute Pancreatitis: A Single-center Real-world Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Major complications or death
研究概览
简要总结
Strategies for invasive intervention in acute pancreatitis include sequential or combined use of multiple drainage and debridement modalities. The more widely used is the step-up approach, which requires an individualized and multidisciplinary (internal medicine, interventional radiology, endoscopy, surgery, critical care medicine, and nutritionists) approach. The available evidence from randomized controlled studies is from highly selected subject populations, and it is unclear whether the results can be applied to complex clinical situations in real clinics, and the optimal strategy for drainage of peripancreatic lesions in different patients still needs to be evaluated in the real world. This study intends to establish a prospective single-center cohort for real-world analysis to collect comprehensive clinic information and clinical outcomes, to evaluate the effectiveness and safety of existing intervention strategies, especially the timing and modality of interventions, in real-world clinical practice, and to explore the key factors affecting patient prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admission diagnosis of acute pancreatitis;
- •Localized complications confirmed by imaging examinations;
- •Voluntary participation in the study and signing of an informed consent form.
排除标准
- •Improved with conservative treatment without invasive interventions for local complications during hospitalization.
结局指标
主要结局
Major complications or death
时间窗: Day 1 from admission until 6 months after discharge
A composite of major complications (i.e., new-onset multiple organ failure or systemic complications, enterocutaneous fistula or perforation of a visceral organ requiring intervention, or intraabdominal bleeding requiring intervention) or death during admission or during the 6 months after discharge.
次要结局
- Systemic complication(Day 1 from admission until 6 months after discharge)
- Enterocutaneous fistula(Day 1 from admission until 6 months after discharge)
- Perforation of visceral organ(Day 1 from admission until 6 months after discharge)
- Organ failure(Day 1 from admission until 6 months after discharge)
- Length of intesive care(Day 1 from admission until the 1 day of discharge)
- Total direct medical costs and indirect costs(Day 1 from admission until the 1 day of discharge)
- Intraabdominal bleeding(Day 1 from admission until 6 months after discharge)
- Pancreatic fistula(Day 1 from admission until 6 months after discharge)
- New-onset diabetes(Day 1 from admission until 6 months after discharge)
- Use of pancreatic enzymes(Day 1 from admission until 6 months after discharge)
- Length of hospitalization(Day 1 from admission until the 1 day of discharge)