The Study of the Natural Way of Development of External Pancreatic Fistulas in Children with Necrotizing Pancreatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- The duration of pancreatic fistula functioning
研究概览
简要总结
The external pancreatic fistula (EPF) is characterized by the leakage of pancreatic juice outward through an area of skinor through a drainage tube.
The leakage of pancreatic juice occurs due to the rupture of the pancreatic duct (PD) caused by the destruction of pancreatic tissue. EPF can cause deterioration in the patient's condition due to the leakage of protein-rich pancreatic juice outward, as well as the increased risk of skin irritation and infection.
详细描述
The treatment of EPF has traditionally been conservative, including the nutritional support in an attempt to reduce pancreatic secretion, or total parenteral nutrition with antisecretory therapy (octreotide). In cases where the conservative therapy has proved to be ineffective, there has been performed the surgical treatment. The cases of successful treatment of EPF by endoscopic transpapillary drainage have been reported in the literature as an effective and minimally invasive therapeutic alternative to the surgery for the treatment of EPF. However, the endoscopic transpapillary drainage is usually ineffective in patients with the complete PD failure. The complete PD failure in the presence of the functional pancreas above the failure results in the disconnected pancreatic duct syndrome.
Sepsis, infection, electrolyte disturbances, malnutrition, and infections are commonly seen in patients with high-output EPF. In addition, there has occasionally been reported the spontaneous closure of low-output EPF. However, there are no data on the natural history of EPF.
The aim of this study is to evaluate the natural clinical history of EPF in children with necrotizing pancreatitis by examining the outcomes and the complications of the conservative treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or legal representative consent
- •External pancreatic fistula
- •Age from 0-18 years
- •Moderate severe (MSAP) or severe acute pancreatitis (SAP) according to Atlanta criteria revisited in 2012
- •Acute Pancreatitis was defined in case of the presence of at least two of the three criteria according to the classification developed by the INSPPIRE (International Study Group of Pediatric Pancreatitis: In Search for a Cure) group: abdominal pain consistent with the diagnostic hypothesis; serum amylase and/or lipase increased by ≥3 times; imaging results typical of AP: abdominal ultrasound and/or contrast-enhanced CT.
排除标准
- •Mild acute pancreatitis
- •Chronic pancreatitis
- •No consent from patient or legal representative
结局指标
主要结局
The duration of pancreatic fistula functioning
时间窗: From the day of surgery to the end of treatment (9 months)
based on testing serum lipase and/or amylase concentrations in drained fluid, imaging results: ultrasound (US), spiral computed tomography (SCT), magnetic resonance imaging (MRI), fistolography
次要结局
- The level of damage to the main pancreatic duct(From the day of surgery to the end of treatment (9 months))
- The duration of hospital stay(From the day of surgery to the end of treatment (9 months))
- The mortality(From enrollment to the end of treatment (9 month))
- The dynamics of the total protein(From enrollment to the end of treatment (9 month))
- The effect of the etiologic factor on the duration of the external pancreatic fistula functioning(From enrollment to the end of treatment (9 month))
- The dynamics of the drain tube fluid amylase(From enrollment to the end of treatment (9 month))
- The dynamics of the blood amylase(From enrollment to the end of treatment (9 month))