跳至主要内容
临床试验/NCT00581698
NCT00581698已完成不适用

Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue

Memorial Sloan Kettering Cancer Center1 个研究点 分布在 1 个国家目标入组 876 人开始时间: 1991年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
876
试验地点
1
主要终点
This is a trial to assess the feasibility of the technique of identifying the sentinel node using the technique of lymphatic mapping as described by Morton. The primary endpoint of the trial will be success or failure in identifying the sentinel node.

研究概览

简要总结

The purpose of this study is to determine whether we can consistently identify the first lymph node (the "sentinel node") draining your melanoma.

详细描述

The issue of elective lymph node dissection (LND) in the management of melanoma patients with clinically negative nodes remains controversial. The concept of elective LND is attractive because it provides the opportunity to detect and remove occult micrometastases before they become clinically apparent. Numerous retrospective analyses have consistently shown a 15-20% long term survival advantage in patients undergoing elective LND who are found to have positive nodes, compared to those undergoing therapeutic LND for clinically positive nodes. The majority of patients undergoing elective LND however, do not have lymph node involvement, and the impact of removal of these negative nodes on the survival of these patients is unknown. The substantial morbidity of these procedures has led to the conduct of a number of important prospective randomized trials designed to define the impact of elective LND on the survival of patients with clinically node negative melanoma. In 1982, the World Health Organization reported on the end results of 553

The primary objective of this protocol is to establish the feasibility of lymph node mapping, using preoperative lymphoscintigraphy and intraoperative blue dye injection to detect the sentinel node in patients at risk for regional lymph node metastasis from their primary melanoma.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • primary melanomas Clark III and Breslow thickness > 1 mm, or Clark IV-V and any Breslow thickness
  • clinically negative regional nodes

排除标准

  • previous definitive wide local excision of the primary melanoma with skin graft
  • an inflammatory lesion in the area of the primary melanoma that is likely to drain to the same nodal basin
  • pregnancy

结局指标

主要结局

This is a trial to assess the feasibility of the technique of identifying the sentinel node using the technique of lymphatic mapping as described by Morton. The primary endpoint of the trial will be success or failure in identifying the sentinel node.

时间窗: 18 years 1 month

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

Loading locations...

相似试验

Intraoperative Mapping of Regional Lymphatics... | 临床试验