Randomized Controlled Study: Comparison Between Extended and Standard Pancreatoduodenectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.
详细描述
In Japan and in some western treatment centers, there has been a general belief that more extensive surgery may improve outcome for patients with localized, operable pancreatic adenocarcinoma. Initial retrospective reports from centers in Japan suggested that 5-year overall survival rates in patients treated with pancreaticoduodenectomy plus extended lymphadenectomy were higher than those in patients treated by pancreaticoduodenectomy with standard lymphadenectomy. Subsequent prospective randomized trials performed in Europe and the United States failed to confirm a survival benefit from extended lymphadenectomy. Although they failed to confirm a survival benefit from extended lymphadenectomy, the studies had a few pitfalls. The need for Well-designed randomised controlled study is the starting point of our study. This study was designed to test the hypothesis that more extensive nodal and soft-tissue clearance in patients with adenocarcinoma of the head of the pancreas would improve survival without an increase in morbidity and mortality.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age : 20- 85 years old
- •No evidence of metastasis and to be possible to resect radically
- •No history of previous radiation therapy or chemotherapy
- •Pathological diagnosis: adenocarcinoma of pancreas
- •Patients who agree and sign the informed consent
- •More than 70 in Karnofsky performance scale
排除标准
- •Past medical history of treatment for other malignant disease
- •Recurred pancreatic cancer patients
- •Patients with R1/R2 resection
- •Patients who underwent neoadjuvant chemotherapy
研究组 & 干预措施
1
standard pancreatoduodenectomy
干预措施: Standard pancreatoduodenectomy (Procedure)
2
extended pancreatoduodenectomy
干预措施: Extended pancreatoduodenectomy (Procedure)
结局指标
主要结局
Survival
时间窗: 2 year after surgery
comparison of 2-year overall survival rate between standard and extended pancreaticoduodenectomy; number of surviving participants 2 years after surgery
次要结局
- Morbidity(within 2 years after surgery)
研究者
Sun-Whe Kim
Professor
Seoul National University Hospital
