Melanoma Clinical Trial
Official title:
Intraoperative Mapping of Regional Lymphatics Draining the Primary Site of Melanoma Using Isosulfan Blue
The purpose of this study is to determine whether we can consistently identify the first lymph node (the "sentinel node") draining your melanoma.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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