Axillary Dissection
Conditions
Keywords
Axillary dissection
Brief summary
Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest.
Detailed description
Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM), involves retrieving all breast related nodes while leaving intact the main lymphatic drainage chain of the upper limb. This represents a new surgical technique that is the focus of recent surgical interest. The assumption is that the sentinel node (SN) of the upper limb is different from the SN of the breast and that it is uninvolved after metastatic involvement of the axillary nodes in relation to the breast. During the ARM procedure, it is necessary to use an injection of a lymphatic tracer into the upper limb in order to visualize the lymphatic arm drainage.The ultimate goal for ARM procedure is to reduce the rate of lymphedema in N+ patients requiring an AD.
Interventions
PROCEDUREAxillary dissection for breast carcinomas
surgery Axillary dissection
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Indication for formal Axillary Dissection (AD) * N0 patient with a large tumor: T3 * N1 patient * N2 patient with axillary imaging showing limited node involvement(1-4N+). * Secondary AD after a positive sentinel node ( pN1, pN1(mi)) * AD after préopérative chemotherapy in a patient initially N+. * Age between 18 and 70 * Signature of the consent form. * Patients beneficiary of the Social Security
Exclusion criteria
* N0 patient with an indication of Sentinel Node biopsy * N2 patient with axillary imaging showing suspected node involvement \>4N+. * N3 patient * Age over 70 * Pregnancy * Blue dye allergy * Mentally deficient patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of the principal objectives is qualified as finding one or more radioactive node in zone D | 1 day | Zone D is the area lateral to the lateral thoracic vein and extending from the second intercostobrachial nerve to the axillary vein. If all radioactive nodes are found below the second intercostobrachial nerve (Zone C, A) or medial to the lateral thoracic vein (Zone A, B) this qualifies a failure of the main objective |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the incidence of metastatic or micro-metastatic disease within the SENTIBRAS node | 15 days | Evaluate the incidence of metastatic or micro-metastatic disease within |
| Evaluate the correlation between clinical and histological results | 15 days | Evaluate the correlation between clinical and histological results |
| Evaluate the morbidity associated with Axillary Dissection. | 1 year, 2 years and 5 years | Evaluate the morbidity associated with Axillary Dissection. |
Countries
France
Outcome results
None listed