Predictive Risk Factors for Pancreatic Fistula Grade C After Pancreaticoduodenectomy: Prospective Large Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Incidence of pancreatic fistula grade C
研究概览
简要总结
Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic Fistula (ISGPF) is associated with a life-threatening complication after pancreaticoduodenectomy(PD). Therefore, The aim of this study is to clarify the risk factors for grade C PF by Japan and Taiwan cooperative project.
详细描述
Pancreatic fistula (PF) grade C, defined by the International Study Group of Pancreatic Fistula (ISGPF) is associated with a life-threatening complication after pancreaticoduodenectomy(PD). The rate of grade C PF has been reported 2.5-6%, however, it is critical complication after PD. A large number of enrolled patients will be needed to clarify the risk factors for grade C PF. Therefore, this study design is prospective large observational study at multi-center in Japan and Taiwan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Disease of pancreatic head or periampullary lesions to require pancreaticoduodenectomy
- •Age: 20 years or older
- •PS (ECOG performance status scale) 0-1 at the time of enrollment
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •patients with severe respiratory disorder required oxygen inhalation
- •patients with severe liver dysfunction
- •patients with chronic renal failure with dialysis
- •patients who are unfit for this study as determined by the attending physician
结局指标
主要结局
Incidence of pancreatic fistula grade C
时间窗: 90 days after pancreaticoduodenectomy
次要结局
- Incidence of postpancreatecomy hemorrhage(PPH)(90 days after pancreaticoduodenectomy)
- Incidence of overall pancreatic fistula (grade A, grade B and grade C)(90 days after pancreaticoduodenectomy)
- Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade C with grade A and grade B(90 days after pancreaticoduodenectomy)
- 90-day mortality(90 days after pancreaticoduodenectomy)
- Incidence of clinical relevant pancreatic fistula (grade B and grade C)(90 days after pancreaticoduodenectomy)
- Cut-off value of drain amylase fluid on POD1 to distinguish pancreatic fistula grade B and C with grade A(90 days after pancreaticoduodenectomy)
- Morbidity(90 days after pancreaticoduodenectomy)
- 30-day mortality(30 days after pancreaticoduodenectomy)
研究者
Hiroki Yamaue
Second Department of Surgery
Wakayama Medical University