Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- complication rate
研究概览
简要总结
Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic factors in oncologic surgery; however, the role of lymph node dissection remains unclear for colorectal cancer liver metastasis.
详细描述
Lymph node status is a definite prognostic factor in oncologic surgery and significantly affects long-term survival, as reported by the tumor staging system of the International Union Against Cancer (IUCC), which is the most widespread classification of malignant tumors worldwide. Regional lymphadenectomy is already the standard procedure that completes hepatic resection in the case of carcinoma arising from the extrahepatic bile duct. However, the indication, extent, and role of lymph node excision are still a matter of discussion, and no clear guidelines exist in patients with colorectal cancer liver metastasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first hepatectomy;
- •age <75 years;
- •absence of severe cardiovascular,pulmonary, or other associated diseases;
- •absence of other malignant disease;
- •absence of distant metastases secondary to colorectal cancer other than liver metastases (except a solitary peritoneal tumor that could be completely resected during hepatectomy); and
- •complete resection of liver metastases confirmed during surgery.
排除标准
- •patient who refuses perihepatic lymphadnectomy
- •medical condition in which surgery cannot be tolerated
结局指标
主要结局
complication rate
时间窗: within 3months
次要结局
- To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival(3 years)
研究者
Won-Suk Lee
Assistant Professor
Gachon University Gil Medical Center