Visceral Lymphatic Mapping Project: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as visceral lymphatic mapping using isosulfan blue, may help find cancer of the pancreas, colon, stomach, small intestine, or gallbladder and find out how far the disease has spread.
PURPOSE: This clinical trial is studying the side effects and how well visceral lymphatic mapping using isosulfan blue works in patients with cancer of the pancreas, colon, stomach, small intestine, or gallbladder.
详细描述
OBJECTIVES:
Primary
- Evaluate the safety and feasibility of visceral lymphatic mapping using isosulfan blue in patients with adenocarcinoma of the pancreas, colon, stomach, small bowel, or gallbladder.
- Evaluate the ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes in the basin are involved with the tumor in these patients.
Secondary
- Compare the results obtained from the sentinel lymph node (i.e., positive or negative for metastatic disease) with the results obtained from the other nodes in these patients.
- Compare immunohistochemical analysis with standard analysis of the sentinel lymph nodes in these patients.
- Evaluate the value of intraoperative touch prep analysis of sentinel lymph nodes in these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor
时间窗: 1 week
Safety, as determined by the number of adverse events resulting from procedure
时间窗: 1 week
Safety will be assessed by documenting the number of adverse clinical events resulting from the procedure
次要结局
未报告次要终点