A Randomized, Multicenter and Prospective Trial of Early Percutaneous Catheter Drainage of Sterile Pancreatic Fluid Collections in Severe Acute Pancreatitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The acute peripancreatic fluid collections (AFPCs) is the most common complication in severe acute pancreatitis (SAP). There are controversies on optimal timing for drainage of APFCs in SAP. The early-stage percutaneous catheter drainage (PCD) of sterile peripancreatic fluid collections is questioned as a result of the major cause of secondary infection. The aim of the present randomized controlled trial is to compare the outcomes in terms of mortality, secondary infection of peripancreatic collections, organ failure, length of hospital/ICU stay and inflammatory biomarkers between the early-stage PCD of sterile AFPCs and conservative therapy.
详细描述
The AFPCs is the most common complication in SAP and debate continues regarding the appropriate timing for drainage of sterile APFCs in SAP patients. Some researchers have reported that the massive amounts of inflammatory mediators in the peripancreatic fluid may aggravate the inflammatory reaction and contribute to organ failure (OF) when liberated into the bloodstream by peritoneal absorption. Additionally, bacterial colonization of APFCs may lead to peritoneal abscess formation and sepsis. In a recent study, Wang et al. revealed that early-stage PCD effectively attenuated the peritoneal pressure and decreased the incidence of infection and OF. Finally, APFCs and secondary infection are considered major causes of alimentary tract hemorrhage. Based on these factors, prompt drainage of APFCs seems reasonable for patients in early SAP. In addition, unlike the original 1992 Atlanta classification guidelines (1992-AC), the revision of the 1992-AC by international consensus in 2012 (2012-RAC) highlighted the significance of persistent OF in the classification of SAP. To be exact, those patients diagnosed with SAP according to the 1992-AC without OF or with transient OF were reclassified as having mild AP (MAP) or moderate severity AP (MSAP) by the 2012-RAC. Therefore, many studies have reported changes in the treatment of SAP in the early stages since the 2012-RAC were published. We have retrospectively analyzed 361 patients with AP and found that the early-stage PCD of sterile APFCs in SAP-2012RAC patients can significantly reduce the mortality rate. However, on the contrary, the mainstream viewpoint holds that drainage is not necessary in the absence of infection of the peripancreatic fluid as the fluid can be absorbed completely and sterile PCD may increase the risk of iatrogenic infection. However, these mainstream views aimed at 1992-AC's SAP patients, which actually contain 2012-RAC's SAP and MSAP. Therefore, we hypothesized that the introduction of new AP severity classification methods may alter the indications for early aseptic drainage of AFPCs.
Does early PCD of sterile APFCs benefits patients or increases the secondary infection rate? In view of these problems, we plan to design a randomized controlled trial to compare the outcomes in terms of mortality, secondary infection of peripancreatic collections, organ failure, length of hospital/ICU stay and inflammatory biomarkers between the early-stage PCD of sterile AFPCs and conservative therapy. The aim of this prospective study is to investigate whether early PCD of sterile AFPCs can be used to SAP patients with AFPCs at early stage.
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
- •Age of 18 years to 70 years; and
- •Pain characteristic of pancreatitis; and
- •Elevated serum lipase or amylase (≥3-fold upper normal range); and
- •Persistent organ failure >48 hours; and
- •Organ dysfunction occurred within 7 days after onset of pain; and
- •Presentation with a width of ≥2cm of APFCs in the peripheral tissues of the pancreas, the cyst of lesser omentum , or the paracolic sulci on CT image.
排除标准
- •History diseases of chronic organ dysfunction; or
- •Traumatic pancreatitis; or
- •Post-endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis; or
- •Severe coagulopathy (INR>2); or
- •Severe thrombocytopenia (PLT≤50×109/L); or
- •No suitable route for puncturing; or
- •Pregnancy; or
- •Absent of informed consent from patient or representative.
研究组 & 干预措施
Puncture and Drainage
The enrolled SAP patients are administered puncture and drainage use 8-F or 10-F pigtail tube under guidance of B ultrasound or CT scan.
干预措施: Puncture and drainage (Device)
Conservative therapy
The enrolled SAP patients are administered conservative therapy and without puncture and prolonged drainage.
结局指标
主要结局
Mortality
时间窗: From date of admisstion until the date of in-hospital death or death within two weeks after discharging, whichever came first, assessed up to 1 year.
Determine and compare the death rates in patients who are administered drainage and conservative therapy: Assess the total number of cases of death in each group (Treatment and control)
次要结局
- New set of organ failure(From date of admisstion until new set of organ failure occurred, assessed up to 100 days)
- Length of hospital/ICU stay(From date of admisstion until the patient is transfered to normal ward or discharge, whichever came first, assessed up to 1 year.)
- Aggressive procedures: open necrosectomy and minimally invasive retroperitoneal necrosectomy(From date of admisstion until the patient receives aggressive procedures, assessed up to 100 days)
- Digestive tract fistula(From date of admisstion until the Digestive tract fistula occurred, assessed up to 100 days)
- Secondary infection of peripancreatic collections(From date of admisstion until the secondary infection of peripancreatic collections occurred, assessed up to 100 days)
- Abdominal hemorrhage(From date of admisstion until the abdominal hemorrhage occurred, assessed up to 100 days)