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Spots Global Cancer Trial Database for Axillary Reverse Mapping in Breast Cancer

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Trial Identification

Brief Title: Axillary Reverse Mapping in Breast Cancer

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

Study ID: NCT05040685

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

Hospital de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain

Contact Details

Name: Carlos Ortega Expósito, MD

Affiliation: Bellvitge Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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