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The clinical relevance of an armpit dissection with sparing of the nodes of the upper extrimity.


- candidate number13734
- NTR NumberNTR3698
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-nov-2012
- Secondary IDs1226 / NL3920201512; METC / CCMO
- Public TitleThe clinical relevance of an armpit dissection with sparing of the nodes of the upper extrimity.
- Scientific TitleThe clinical relevance of axillary reverse mapping: A multicenter randomised controlled trial.
- ACRONYMARM: Axillary Reverse Mapping
- hypothesisThe hypothesis is that patients undergoing an axillary lymph node dissecion with preserving of the lymph nodes and vessels of the upper extrimity (ALND-ARM) have less postoperative complications compared to patients undergoing a standard axillary lymph node dissection (ALND-standard).
- Healt Condition(s) or Problem(s) studiedBreast cancer, Breast cancer related lymphedema, Axillary lymph node dissection, Axillary reverse mapping
- Inclusion criteriaFemale 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.
- Exclusion criteriaPrimary 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate1-jan-2016
- Target number of participants280
- InterventionsA standard ALND compared with a limited and more tailor-made axillary lymph node dissecion, based on the ARM technique.
- Primary outcomeLymphedema of the upper extrimity.
- Secondary outcomeThe secondary outcome measurements include other postoperative complications (pain, paresthesia, numbness and loss of shoulder mobility), quality of live and axillary recurrence ratio.
- TimepointsFollow-up will be performed at 6, 12 and 24 months after the primary intervention
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. Paul D. Gobardhan
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Paul D. Gobardhan
- Sponsor/Initiator Amphia hospital
- Funding
(Source(s) of Monetary or Material Support)
Pink Ribbon
- PublicationsGobardhan 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.
- Brief summaryBackground:
Axillary lymph node dissection has potential negative side effects associated with the procedure including upper extremity lymphedema.1-9 Axillary reverse mapping (ARM) is a recently described technique which enables discrimination of lymphatic drainage of the breast from the arm. If upper extremity lymphedema is caused by cutting axillary lymphatic’s, then being able to see and identify them would allow them to be preserved.10 The aim of this study is to determine the clinical relevance of ARM expressed by the occurrence of postoperative complications. To minimize the risk overlooking ARM node metastases, we will only include patients with an indication for a complementary axillary lymph node dissection based on a tumor-positive sentinel lymph node. Patients with an indication for an axillary lymph node dissection based on a clinical positive axilla can be included in the feasibility study to confirm the feasibility of the procedure and to perform a further subgroup analysis.

Methods and design:
280 Patients diagnosed with axillary metastasis of invasive breast cancer and an indication for a complementary axillary lymph node dissection based on a positive sentinel lymph node will be randomised to receive an axillary lymph node dissection with sparing of the ARM nodes and a standard axillary lymph node dissection. The postoperative outcome will be measured after 6,12 and 24 months. The primary outcome is the presence of breast cancer related lymphedema.
The secondary outcome measurements include other postoperative complications (pain, paresthesia, numbness and loss of shoulder mobility), quality of live and axillary recurrence ratio.
- Main changes (audit trail)
- RECORD8-nov-2012 - 24-nov-2012


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