Axillary Reverse Mapping in Breast Cancer (ARM)

Catalan Institute of Health

Status

Completed

Conditions

Lymph Node Cancer Metastatic

Treatments

Procedure: Axillary mapping reverse

Study type

Interventional

Funder types

Other

Identifiers

NCT05040685

PR139/21

Details and patient eligibility

About

The axillary mapping reverse (ARM) consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.

A significant decrease of lymphedema rates in patients who was possible associate ARM technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques like fluorescence dye.

Full description

Axillary lymph node dissection (ALND) was the standard therapy until 1990-2000, when the technique was replaced, when possible, by another procedure associated with less morbidity: the sentinel lymph node biopsy (SLNB). However, actually, ALND is still the gold standard in some patients. This procedure is associated with substantial morbidity, like lymphedema, shoulder pain, arm numbness, axillary web syndrome and decreased upper-extremity range of motion (ROM), that severely conditions the quality of life of these patients.

In 2007, the investigators had the first reports about a new surgical technique, the axillary mapping reverse (ARM), that consists in differentiating the upper limb lymph nodes from the breast ones in order to preserve them and reduce the possibility of lymphedema.

The current literature shows a significant decrease of lymphedema rates in patients who was possible associate this technique during the axillary surgery improving the quality of life of these patients. There are different visualisation techniques. With the use of indocyanine green, the visualisation rates in the axilla of ARM lymphatics are from 88%, similar to other techniques. Some advantages of fluorescence dye are that no systemic allergic reactions have been reported and the 'green tattoo' disappears quickly.

HYPHOTESIS The axillary mapping reverse (AMR) is able to identify the lymph nodes responsible for lymphatic drainage of the ipsilateral upper limb (ARM nodes) in breast cancer patients who underwent an axillar lymph node dissection.

Enrollment

43 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patients who will undergo ALND in the treatment of breast cancer:

cT4a, cT4c and cT4d.
cT4b with extensive involvement of the skin.
cN0 with SLNB positive (pN+) that need to associate ALND:
- cT3-T4b.
- >2 lymph node macrometastasis if cTis, cT1 and cT2.
- Patients who underwent mastectomy and it is not possible associate adjuvant radiotherapy.
cN1:
- If primary surgery treatment.
- After neoadjuvant systemic treatment, if there is not a clinical-radiological complete response and/or SLNB positive (ypN+).
cN2:
- If primary surgery treatment.
- After neoadjuvant systemic treatment, if luminal tumours or there is not a clinical-radiological complete response in triple negative or HER2 overexpressed tumours.
cN3.