NCT00918853已完成不适用
Prospective Evaluation of the Resection Margins and the Ganglionic Status Using a Quality Standard Resection for Adenocarcinoma of the Head of the Pancreas.
Institut Paoli-Calmettes20 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2008年8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
- 156
- 试验地点
- 20
- 主要终点
- Prognostic value of the invasion of the margins measured in millimetres on the overall survival
研究概览
简要总结
This multicentric prospective study evaluates the role of the margins resection and the ganglionic status when using a quality standard for the resection of adenocarcinoma of the head of the pancreas.
详细描述
Primary objective:
- Evaluation of the prognosis role of the invasion of the margins on the overall survival after a standard resection of adenocarcinoma of the head of the pancreas.
Secondary objectives:
-
Evaluation of the prognosis role of the invasion:
-
Of margins on the overall survival.
-
Of each margins (distal pancreatic margin, gastric, posterior, retro-venous, retro-arterial) on the overall survival.
-
Of the ganglionic group of the superior mesenteric artery and the other nodes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A head of the pancreas tumor compatible with adenocarcinoma diagnosis
- •tumor apparently removable
- •patient aged from 18 to older
- •signed consent
- •Non inclusion criteria:
- •pregnancy, breast feeding
- •patient in an urgency situation or patient with legal protection
排除标准
- •after surgery:
- •tumor other than adenocarcinoma of the head of the pancreas.
- •analysis of the margins not done with the defined criteria
- •nonadhesion to the surgical protocol
结局指标
主要结局
Prognostic value of the invasion of the margins measured in millimetres on the overall survival
时间窗: 4 years
次要结局
- Relapse free survival: time between surgery and relapse or a right censure. The relapse is determined by clinical examination, biologic examination and imaging, which reveals metastasis or an isolated local relapse(4 years)
研究者
研究点 (20)
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