NCT05040685

Axillary Reverse Mapping in Breast Cancer

Axillary Reverse Mapping (ARM): Validation of Surgical Tecnique in Breast Cancer Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Hospital Universitari de Bellvitge · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Lymph Node Cancer Metastatic

Interventions

Type	Name	Description
PROCEDURE	Axillary mapping reverse	At the time of performing the ALND associate the ARM, injecting between 2-5mL of indocyanine green subcutaneously in the ipsilateral upper extremity at the medial inter-muscular and massaged for 5 min. First, identify the ARM nodes by indocyanine green, then perform conventional axillary lymphadenectomy trying to preserve the ARM nodes. And, in a second time, extract ARM nodes for their individualized anatomopathological study.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2021-09-10
• Last updated: 2024-02-28

Locations

1 site across 1 country: Spain