The clinical relevance of axillary reverse mapping (ARM)
- Conditions
- lymfedemaswelling1002765610006295
- Registration Number
- NL-OMON39541
- Lead Sponsor
- Amphia Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 280
Female mental competent patients of at least 18 years of age with the diagnosis invasive breast cancer with an indication for a complementary axillary lymph node dissection (ALND) based on a positive sentinel lymph node (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.
Exclusion criteria are: primary ALND based on a clinical positive axilla (proven by cytological punction), a contra-indication for sentinel lymph node biopsy (SLNB), a history of breast-cancer, adverse event during the previous SLNB, pregnancy.
Patients excluded for randomization between ALND and ALND-ARM will be possible candidates for the side study in which the feasibility of ARM (without sparing lymphatics and lymph nodes) is investigated.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Randomisation study:<br /><br>Complications will be measured after 6, 12 and 24 months after the primary<br /><br>procedure by a nurse practitioner/clinical investigator. The primary end-points<br /><br>of the study are the presence of physical complains consisting of lymphoedema,<br /><br>pain, numbness, loss of shoulder mobility.<br /><br><br /><br>Primary endpoints:<br /><br>- Breast cancer related lymphoedema (BCRL)<br /><br>- Paraesthesia/numbness<br /><br>- Pain<br /><br>- Loss of arm and shoulder mobility<br /><br><br /><br>Secundary endpoints:<br /><br>- Quality of live<br /><br>- Axillary recurrende rate<br /><br><br /><br>Feasibility (side-study):<br /><br>- identification of ARM-nodes<br /><br>- Involvement of the ARM-nodes in the metastatic proces</p><br>
- Secondary Outcome Measures
Name Time Method <p>Randomisation study:<br /><br>Secondary endpoints:<br /><br>- Quality of life (QOL)<br /><br>- Axillary recurrence rate<br /><br><br /><br>Disease free survival during the first 5-10 years will be documented during the<br /><br>routinely control at the outpatient clinic.<br /><br><br /><br>Feasibility (side-study):<br /><br>n.a.</p><br>