Axillary Reverse Mapping for Breast Carcinomas

Assistance Publique - Hôpitaux de Paris210 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

210

Conditions

Axillary Dissection

Interventions

Axillary dissection for breast carcinomasPROCEDURE

surgery Axillary dissection

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital European Georges Pompidou

Paris, France

Outcomes

Primary Outcomes

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

Time frame: 1 day

Secondary Outcomes

Evaluate the incidence of metastatic or micro-metastatic disease within the "SENTIBRAS " node

Evaluate the incidence of metastatic or micro-metastatic disease within

Time frame: 15 days

Evaluate the correlation between clinical and histological results

Time frame: 15 days

Evaluate the morbidity associated with Axillary Dissection.

Time frame: 1 year, 2 years and 5 years

Data from ClinicalTrials.gov

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