NCT03267966已完成不适用
Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial
Campus Bio-Medico University0 个研究点目标入组 168 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 主要终点
- R1 resection rate
研究概览
简要总结
This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other "conventional" pathological protocol of PD specimen for periampullary cancer. Our aims were to evaluate the impact of the protocol and of the clearance on R1 rate and its prognostic value.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pancreaticoduodenectomy for periampullary cancer
排除标准
- •diagnosis of neuroendocrine neoplasm;
- •previous pancreatic surgery;
- •frozen section of each transection margins not performed or presence of positive transection margins without further resection (R1 intraoperative resection);
- •presence of macroscopic residual tumor (R2 resection).
结局指标
主要结局
R1 resection rate
时间窗: 1 month
To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance
次要结局
- pathological data(1 month)
- oncological results(60 months)
研究者
Gennaro Nappo
M.D.
Campus Bio-Medico University
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