A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During Distal Pancreatectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 12
- 主要终点
- Incidence of pancreatic fistula grade B/C
研究概览
简要总结
The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.
详细描述
Reducing the incidence of pancreatic fistula is the most important issue in pancreatectomy. There is no certain view on the pancreatic resection method to reduce pancreatic fistula in distal pancreatectomy.This study will be conducted to scientifically investigate the impact of Endo GIA Reinforced Reload with Tri-Staple Technology in distal pancreatectomy. The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •disease of pancreatic body and tail
- •PS (ECOG Performance Status Scale)0-1
- •Age: 20 years or older
- •distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis
- •Patients who can provide written informed consent
排除标准
- •Patients with severe ischemic cardiac disease
- •Patients with severe liver cirrhosis or active hepatitis
- •Patients with respiratory illness that requires oxygen administration
- •Patients with chronic renal failure requiring dialysis
- •Patients requiring other organ resection
- •Patients who are unfit for the study as determined by the attending physician
结局指标
主要结局
Incidence of pancreatic fistula grade B/C
时间窗: Ninety days after operation
次要结局
- Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma(Ninety days after operation)
- Incidence of intraabdominal bleeding(Ninety days after operation)
- Postoperative hospital stay(Ninety days after operation)
- Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line(during operation)
- Period of drain insertion(Ninety days after operation)
- Damage of pancreatic stump(during operation)
- Frequency of additional suture of pancreatic stump(during operation)
- Incidence of pancreatic fistula defined by ISGPF classification(Ninety days after operation)
- Incidence of pancreatic fistula grade C defined by ISGPF classification(Ninety days after operation)
- Morbidity(Ninety days after operation)
- Mortality(Ninety days after operation)
- Hemostasis condition of staple line(during operation)
研究者
Hiroki Yamaue
Second Deaprtment of Surgery
Wakayama Medical University