Timing of Surgical Intervention After Percutaneous Catheter Drainage in STEP UP Approach for Severe Acute Pancreatitis: a Randomized Controlled Stud
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Mortality
研究概览
简要总结
- To determine the appropriate timing of surgical intervention after Percutaneous Catheter Drainage (PCD) in infected pancreatic necrosis (IPN).
- To see the change in morbidity and mortality after changing the interval of surgery after PCD
详细描述
In present study we plan to determine the appropriate timing of surgical intervention after PCD in step up approach of Infected pancreatic necrosis (IPN).
The investigators also intend to evaluate the role of PCD in obviating the surgical intervention in the management of IPN and evaluate the risks & benefits of extended treatment policy of PCD in step up approach of IPN in comparison to early surgery after PCD.
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
- 14 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with diagnosis of IPN (UK GUIDELINES) managed with percutaneous catheter drainage (PCD) for 10 to 15 days and not showing significant improvement on PCD will be included
排除标准
- •Patient showing significant improvement on PCD within 10 days of its insertion.(Significant improvement on PCD is defined as resolution of fever, acceptance of enteral nutrition, decrease in total leukocyte count, reversal of organ system failure)
- •Sterile pancreatic necrosis
- •An acute intra abdominal event ( perforation of hollow viscus, bleeding, or the abdominal compartment syndrome) during or within 10 days after PCD insertion
- •Previous drainage or surgical necrosectomy for infected pancreatic necrosis (ERCP with or without papillotomy is allowed.)
- •Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy
研究组 & 干预措施
Group A
undergo surgery between days 10 - 15 after PCD
干预措施: surgical intervention after percutaneous catheter drainage (Procedure)
Group B
continued with PCD beyond 15 days and indications for surgery in them will be,
- Persistent sepsis or symptoms
- Worsening of clinical condition
- Failure to thrive
- Complications of SAP or PCD
干预措施: surgical intervention after percutaneous catheter drainage (Procedure)
结局指标
主要结局
Mortality
时间窗: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Reversal of existing organ failure
时间窗: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
New onset multiorgan failure or sepsis and systemic complications
时间窗: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Locoregional complications
时间窗: participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks
Pseudocyst, Pancreatic fistula, Enteric fistula, Perforation of a hollow viscus, and bleeding requiring intervention
次要结局
- Pancreatic insufficiency (New onset Diabetes and steatorrhea)(participants will be followed for the duration of hospital discharge to end of our study period, an expected average duration of 1 year)
- Proportion of patients in which surgery would be avoided in Group B(participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks)
- Total number of PCD catheters and catheter related interventions required, and catheter and drain related complications(participants will be followed for the duration of hospital stay, an expected average duration of 5 weeks)
研究者
Rajesh Gupta
Professor
Post Graduate Institute of Medical Education and Research, Chandigarh