Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

total mastectomy

Elodie Demblocque, MD

Albine Mancaux, MD

Pierrick Theret, MD

Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population.

The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy.

In France, Ambulatory care is developed as part of the new national health plan.

Breast conserving surgery for tumorectomy or partial mastectomy is already done in outpatient vacation.

Total mastectomy is an extension of this surgery, and, as such, underpins the investigator's hypothesis that total mastectomy is feasible in outpatient care .

Feasibility of Total Mastectomy in Ambulatory Care

Post Anaesthetic Discharge Scoring System (PADSS), which considers six criteria: vital signs, ambulation, nausea/vomiting, pain, bleeding and voiding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a score of 9 or more are considered ready for discharge.

Centre Hospitalier de Beauvais

Centre Hospitalier de Saint-Quentin

Centre Hospitalier Universitaire, Amiens

Symptoms and General Pathology

Neoplasm Metastasis

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Patient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s). If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction) performed.

If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected.

Fine Needle Aspiration (FNA)

Patient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s).

Ultrasound

Patient receives standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction).

Breast Surgery + Lymph Node Removal

Henry Kuerer, MD,PHD

The goal of this clinical research study is to learn if it is feasible to use find (using ultrasound) and surgically remove cancer that has spread to the lymph nodes, during routine lymph node surgery.

In standard care, all affected lymph nodes are removed. In this study, however, the cancerous lymph nodes will be removed separately and then the rest of the lymph nodes under the arm will be removed after that.

Before surgery, patient may or may not receive the standard chemotherapy drug(s) that their doctor recommends. If patient's doctor suggests chemotherapy before surgery, they will be asked to sign a separate consent form that describes the chemotherapy and its risks.

On the day of surgery, patient will have an ultrasound of their lymph nodes. If patient has received chemotherapy before their surgery, they will have a fine needle aspiration (FNA) of any abnormal lymph nodes either right before or during their standard breast and underarm surgery. The abnormal lymph nodes will be marked for the surgeon to remove using standard techniques with either ultrasound, a mammogram, or 125I-seed placement. To perform an FNA, the area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected. Ultrasound imaging is used to guide the needle into the area. The cells will be used for research to learn if the chemotherapy killed the abnormal lymph node cells.

Patient will have standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction). Patient's doctor will discuss the surgery with patient in more detail and patient will be asked to sign a separate consent form.

During this surgery, the 1 or 2 abnormal underarm lymph nodes found by ultrasound will be removed and sent as separate samples before the rest of the underarm lymph nodes are removed.

Patient's study participation will be complete after surgery.

This is an investigational study. The surgery in this study is standard treatment. It is investigational to remove the abnormal lymph nodes before the rest of the underarm lymph nodes are removed. In this study, the exact same number of lymph nodes would be removed as is standard, but the surgery is being done in a 2-step process.

Up to 12 patients will take part in this study. All will be enrolled at MD Anderson.

Selective Image Guided Resection of Axillary Lymph Nodes

Feasibility of Selective Image Guided Resection of Cytologically Documented Axillary Lymph Node Metastases

Patients required to have a minimum of at least two nodal ultrasounds: once at diagnosis and once prior to surgery. Marker clip placed in the one or two abnormal node(s) at diagnosis and on day of surgery. Nodes localized by ultrasound (or by mammographic or 125I-seed localization if not visualized well with ultrasound) for excision, and fine needle aspiration (FNA) repeated of previous abnormal nodes. Patients undergo standard breast and axillary surgery. During surgery the one or two abnormal axillary nodes identified by ultrasound are removed. The lymph nodes excised with the clip will be evaluated with specimen x-ray. If no marker clip is identified in the lymph node(s), the axillary contents will be x-rayed to document removal of the marker clip. Procedure considered a success if all marker clips are successfully identified in the preoperative ultrasound and documented in a lymph node via postoperative specimen x-ray of the excised material.

Secondary objective defined as determination of whether the excised node contains metastases or not (defined as a lymph node with a metastasis greater than 0.2 mm in greatest dimension identified by H\&E staining) and recording the presence or absence of residual metastases by repeat fine needle aspiration (FNA) at the time of surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of Total Mastectomy in Ambulatory Care	NCT04270136	Breast Cancer Mastectomy Ambulatory Care	total mastectom...	18 Years -	Centre Hospitalier Universitaire, Amiens
Selective Image Guided Resection of Axillary Lymph Nodes	NCT01880645	Breast Cancer	Fine Needle Asp... Ultrasound Breast Surgery ...	18 Years -	M.D. Anderson Cancer Center
Feasibility of Total Mastectomy in Ambulatory Care	NCT04270136	Breast Cancer Mastectomy Ambulatory Care	total mastectom...	18 Years -	Centre Hospitalier Universitaire, Amiens

Spots Global Cancer Trial Database for total mastectomy