NEW SURGICAL APPROACHES FOR THE MANAGEMENT OF MALIGNANT MELANOMA

治疗恶性黑色素瘤的新手术方法

• 批准号: 6424519
• 负责人: DONALD L MORTON
• 金额: $ 79.41万
• 依托单位: SAINT JOHN'S CANCER INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-02-23 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6424519
• 关键词: clinical research; clinical trials; diagnosis design /evaluation; diagnosis quality /standard; histopathology; human subject; human therapy evaluation; lymph nodes; lymphadenectomy; melanoma; metastasis; method development; neoplasm /cancer classification /staging; neoplasm /cancer radionuclide diagnosis; neoplasm /cancer relapse /recurrence; neoplasm /cancer surgery; oncology; preoperative state; prognosis

The primary objective of this project is to develop new approaches to the surgical management of cutaneous melanoma. In this regard, a major controversy exists over whether early lymph node dissection in patients with clinically negative (non-palpable lymph nodes offers any therapeutic advantage over observation and later dissection when the patient has developed clinically obvious nodal metastases. Since only 20% of such patients will have micrometastases found at the time of elective node dissection, 80% of such patients will be exposed to the morbidity and expense of an operative procedure from which they can derive no benefit. In this context, lymphatic mapping and sentinel lymphadenectomy (SLND) was proposed as a method to pathologically stage the regional lymph nodes without performing elective LND. Only patients with histologically proven sentinel node (NS) metastasis undergo complete LND. Thus, LND can be undertaken earlier for regional metastasis, and can be avoided completely in the absence of regional involvement thus sparing those with tumor free SN the morbidity of radical node dissection. This makes SLND a rational alternative to routine elective LND or nodal observation. Studies performed at institutions across the world have verified the validity of the SN concept and accuracy of SLND as a staging procedure. The specific aims of the proposal are to continue research on the development of these concepts and determine whether the techniques provide a survival benefit for melanoma. Aim 1- Conduct a multi-center trial which evaluate the application for intraoperative lymphatic mapping and selective lymphadenectomy for the management of clinical stage I melanoma. Aim 2- Improve the accuracy of sentinel node identification by improvements in surgical pathology technology. Aim 3- Develop more sensitive and accurate methods for identifying patients with systematic subclinical melanoma micrometastases, alone or combined with regional nodal metastases.

该项目的主要目标是开发新方法 皮肤黑色素瘤的手术治疗。对此，一个主要的 对于患者是否应早期进行淋巴结清扫存在争议 临床阴性（不可触及的淋巴结提供任何治疗 当患者有以下情况时，优于观察和随后的解剖： 出现临床上明显的淋巴结转移。因为只有 20% 是这样的 患者在选择性淋巴结时会发现微转移 解剖，80％的此类患者将面临发病率和 他们无法从中获得任何好处的手术费用。 在这种情况下，淋巴标测和前哨淋巴结切除术（SLND） 提出作为区域淋巴结病理分期的方法 不进行选择性 LND。只有经组织学证实的患者 前哨淋巴结（NS）转移接受完整的 LND。因此，LND 可以是 局部转移较早进行，可以完全避免 在没有区域受累的情况下，从而避免那些无肿瘤的人 SN 根治性淋巴结清扫的发病率。这使得 SLND 成为理性的 常规选择性 LND 或淋巴结观察的替代方案。研究 在世界各地的机构进行的验证了 SN 概念和 SLND 作为分期程序的准确性。 该提案的具体目标是继续研究 发展这些概念并确定这些技术是否提供 黑色素瘤的生存获益。 目标 1 - 进行多中心试验，评估该申请 术中淋巴标测和选择性淋巴结切除术 临床 I 期黑色素瘤的治疗。 目标2-通过以下方式提高哨兵节点识别的准确性 外科病理学技术的进步。 目标 3 - 开发更灵敏、更准确的识别方法 患有系统性亚临床黑色素瘤微转移的患者，单独或 合并局部淋巴结转移。