Management of Sterile Fluid Collections in Patients With Severe Acute Pancreatitis:a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- pancreatic infection
研究概览
简要总结
Acute fluid collections is common in patients with severe acute pancreatitis (SAP). But the treatment for this is controversial. In this study, the investigators aim to evaluate the different effects of three different treatment protocols which is repeated aspiration, continuous catheter drainage and conservative treatment. The investigators suppose repeated aspiration could not only solve acute fluid collections, but also lower the rate of pancreatic infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms and signs of acute pancreatitis according to Atlanta criteria and if pancreatic or/and peripancreatic fluid collections were confirmed by ultrasound and computed tomography examination
- •CT density < 30Hu
- •Within 7 days from the onset of the disease
- •Available approach for percutaneous penetrate
排除标准
- •Pregnant pancreatitis
- •Receiving surgery or aspiration before;need of early surgery
- •Infected fluid collection
研究组 & 干预措施
Conservative treatment
Conservative treatment group with only drugs.
干预措施: Conservative treatment (Drug)
Continuous catheter drainage
Once the diameter of the fluid collection is more than 6cm, continuous catheter drainage will be applied.
干预措施: Catheter drainage (Procedure)
Repeated aspiration
Once the diameter of the fluid collection is more than 6cm, aspiration is applied and draw the tube out immediately after aspiration.
干预措施: Aspiration (Procedure)
结局指标
主要结局
pancreatic infection
时间窗: 28 days
mortality
时间窗: 28 days
次要结局
- inflammation parameters(28 days)
- intra abdominal pressure(28 days)
- complications(28 days)
- ICU duration(day one until discharge)
- hospital duration(day one until discharge)
- SIRS(28 days)
- MODS(28 days)
研究者
Weiqin Li
Director of surgical ICU
Nanjing University School of Medicine