Roux-en-Y Anastomosis of the Pancreatic Stump Following Distal Pancreatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 2
- 主要终点
- Incidence of pancreatic fistula defined by ISGPF classification
研究概览
简要总结
The objective is to clarify Roux-en-Y anastomosis of the pancreatic stump decreases pancreatic fistula following distal pancreatectomy, compared with stapling closure of the pancreatic stump.
详细描述
The objective of this study was to clarify Roux-en-Y anastomosis of the pancreatic stump prevents pancreatic fistula after distal pancreatectomy (DP) compared to stapling closure of the pancreatic stump in a prospective randomized controlled trail.
Various methods and technique for treating surgical stump of the remnant pancreas have been reported to reduce pancreatic fistula after DP. However, appropriate surgical stump closure after DP is still controversial.
The primary endpoint in this trial was defined as the incidence of pancreatic fistula .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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.
- •Adequate organ functions filled the following criteria within two weeks from enrollment:
- •1.White blood cell： >3,500/mm3 or <12,000/mm3 2.Neutrophilic leukocyte >2,000/mm3 3.Platelet>100,000/mm3 4.Hemoglobin > 9.0g/dL 5.Total bilirubin <2.0mg/dL 6.AST and ALT<150IU/L 7.Creatinine <1.5mg/dL 6)Patients who can provide written informed consent
排除标准
- •Patients with severe liver cirrhosis or active hepatitis
- •Patients with respiratory illness that requires oxygen administration
- •.Patients with chronic renal failure requiring dialysis
- •Patients with active duplicative malignant disease affecting adverse event
- •Others, 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 defined by ISGPF classification
时间窗: 3 month after operation
次要结局
- postoperative hospital stay(3 month after operation)
- Incidence of pancreatic fistula grade B/C stratified based on thickness of pancreas parenchyma(3 months after oepration)
- morbidity(3 months after opeartion)
- nutritional status(2 years after opeartion)
- Incidence of pancreatic fistula gradeB/C defined by ISGPF classification(3 months after oepration)
- quality of life(2 years after operation)
- new onset or worsening diabetes(2 years after opeartion)
- mortality(3 months after operation)
- Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma(3 months after operation)
研究者
Hiroki Yamaue
Second Department of Surgery
Wakayama Medical University