Axillary Reverse Mapping for Breast Carcinomas

Study Overview
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Brief Summary
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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
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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.

Official Title
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Individualisation of the Lymphatic Arm Drainage During Axillary Dissection for Breast Carcinomas.

Conditions
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Axillary Dissection

Intervention / Treatment
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* Procedure: Axillary dissection for breast carcinomas


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery Axillary dissection<br>surgery Axillary dissection | Procedure: Axillary dissection for breast carcinomas<br>* surgery Axillary dissection<br>* Other names: surgery Axillary dissection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of the principal objectives is qualified as finding one or more radioactive node in zone D | 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 | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the incidence of metastatic or micro-metastatic disease within the SENTIBRAS  node | Evaluate the incidence of metastatic or micro-metastatic disease within | 15 days | 
| Evaluate the correlation between clinical and histological results | Evaluate the correlation between clinical and histological results | 15 days | 
| Evaluate the morbidity associated with Axillary Dissection. | Evaluate the morbidity associated with Axillary Dissection. | 1 year, 2 years and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axillary dissection