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

Phase 3
18 Years
70 Years
Open (Enrolling)
Axillary Dissection

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Trial Information

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

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.

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Success of the principal objectives is qualified as finding one or more radioactive node in zone D

Outcome Description:

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

Outcome Time Frame:

1 day

Safety Issue:


Principal Investigator

Claude NOS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

November 2009

Completion Date:

April 2012

Related Keywords:

  • Axillary Dissection
  • Axillary dissection
  • Breast Neoplasms
  • Carcinoma