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临床试验/NCT01351974
NCT01351974已完成不适用

Cohort Study of Axillary Recurrences and Survival After Negative Negative Sentinel Node Biopsy Without Completion Axillary Clearance

Uppsala University1 个研究点 分布在 1 个国家目标入组 3,369 人开始时间: 2000年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,369
试验地点
1
主要终点
Axillary recurrence after negative sentinel node biopsy

研究概览

简要总结

Axillary lymph node dissection (ALND) was previously the standard axillary staging procedure in breast cancer patients. However, ALND is accompanied by a considerable morbidity, and sentinel lymph node biopsy (SLNB) evolved as a mean to decrease this morbidity. Between September 2000 and January 2004 breast cancer patients were included in the Swedish Sentinel Node Multicenter Cohort Study with the intent of studying axillary recurrence after negative SLNB for patients in which completion ALND were omitted. The patients were followed prospectively and events (local, regional and distant recurrences and deaths) were registered. The primary endpoint was axillary recurrence and secondary endpoints were disease-free, cancer-specific and overall survival.

详细描述

Axillary lymph node dissection (ALND) was previously the standard axillary staging procedure in breast cancer patients. However, ALND is accompanied by a considerable morbidity, including seroma formation, lymphedema, neuropathy of the arm with numbness, stiffness, impaired shoulder movement and pain. Sentinel lymph node biopsy (SLNB) has evolved as a mean to decrease this morbidity, and validation studies have demonstrated the accuracy of the method.

With the intent of studying axillary recurrence after negative SLNB for patients in which completion ALND were omitted, consecutive breast cancer patients were included in the Swedish Sentinel Node Multicenter Cohort Study between September 2000 and January 2004.

Patients with a unifocal, invasive breast cancer less than 3 cm in diameter were eligible for enrollment. Exclusion criteria were palpable regional lymph nodes, neoadjuvant chemo- or radiotherapy, pregnancy, known allergic reactions to blue dye or isotope, previous surgery in the ipsilateral breast, and preoperatively diagnosed tumor multifocality.

Surgical procedure:

After the preoperative injection of 40-60 mBq Technetium-99 nanocolloid (Solco Nanocoll®) and 1 ml blue dye (Patent Blue V®), sentinel lymph node (SLN) biopsy was performed. If no sentinel node could be identified, ALND of levels I and II was performed. A completion ALND was also performed in the event of a positive SLN biopsy, if lymph nodes clearly suspicious of metastasis were detected during surgery, or if the primary tumor in the breast was found to be multifocal on pathological examination.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Primary invasive breast cancer

排除标准

  • Preoperatively diagnosed axillary metastases
  • Multifocal tumors
  • Tumors > 3 cm
  • Impalpable tumors
  • Earlier resection of the tumor
  • Neoadjuvant treatment
  • Pregnancy

结局指标

主要结局

Axillary recurrence after negative sentinel node biopsy

时间窗: 5 years

Prospective follow-up of axillary recurrences in patients with negative sentinel lymph node biopsy in which completion axillary lymph node dissection were omitted

次要结局

  • Survival(5 years)

研究者

发起方
Uppsala University
申办方类型
Other

研究点 (1)

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