The clinical relevance of an armpit dissection with sparing of the nodes of the upper extrimity.
- Conditions
- Breast cancer, Axillary lymph node dissection, Breast cancer related lymphedema, Axillary reverse mapping
- Registration Number
- NL-OMON28839
- Lead Sponsor
- none
- Brief Summary
Gobardhan PD, Wijsman JH, van Dalen T, Klompenhouwer EG, van der Schelling GP, Los J, et al. ARM: axillary reverse mapping - The need for selection of patients. Eur J Surg Oncol. 2012 May 17, Epub ahead of print.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 280
Female patient aged 18 years and over presenting in one of the participating hospitals with the diagnosis invasive breast cancer and an indication for a complementary ALND based on a positive SLN are eligible for an ALND-ARM procedure. The indication for a complementary ALND will be made in a multidisciplinary team including an oncologic surgeon, medical oncologist, pathologist, radiologist and a radiotherapist.
Primary ALND based on a clinical positive axilla, a contra-indication for SLNB, a history of (breast) cancer, an adverse event during the previous SLNB and pregnancy will be excluded from participation of the RCT.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ymphedema of the upper extrimity.
- Secondary Outcome Measures
Name Time Method The secondary outcome measurements include other postoperative complications (pain, paresthesia, numbness and loss of shoulder mobility), quality of live and axillary recurrence ratio.