Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
study patients; axillary node negative breast cancer female, 74 patients randomly allocated in two groups each 37 patients , group I , where axillary reverse mapping(ARM) +ve nodes were preserved and axillary lymph node dissection completed.and group II where axillary reverse mapping +ve nodes were taken with axillary lymph node dissection(ALND) primary outcome is histopathological examination of a ARM +ve lymph nodes and volume measurements of the ipsilateral arm for development of lymphedema at 6 ,12 , and 24 months
This study is comparative clinical trial carried out in the period between February 2015 and August 2019 on 74 female patients with early breast cancer. All patients were informed and signed a written consent. The study was approved from institutional review board (IRB) and ethical committee of our university.
Patient selection Patients included in the study are female patients above 18 years old, known breast cancer with clinically negative nodal metastasis who were admitted for completion ALND, after positive sentinel lymph node biopsy (SLNB).
Patients excluded from the study are those who had received chemotherapy for breast cancer, recurrent cases after conservative breast surgery, bilateral disease and pregnant cases.
Patients were randomly divided into two equal groups each 37 patients, group A; (ARM preserving ALND), where arm lymphatics and lymph nodes were identified and preserved, subsequently ALND was completed, group B; where arm lymphatics and lymph nodes were identified, marked and removed with ALND.
Technical procedures:
Axillary reverse mapping (ARM) procedure; one to two ml of methylene blue dye was subcutaneously injected in the upper medial arm in the groove between biceps muscle and triceps muscle then subsequently the area of injection was massaged for 5 minutes. During axillary dissection the (ARM) positive lymphatics and lymph nodes were identified and carefully dissected as the lymphatic vessels are very delicate, in group A the (ARM) positive lymphatics and lymph nodes were preserved and axillary clearance was completed, in group B (ARM) positive lymphatics and lymph nodes were identified, dissected, marked and taken out with ALND. The procedures were carried out with oncological surgeons familial with ALND. The limits of axillary dissection was axillary vein from above, lateral border subscapularis muscle laterally and medial border of pectoralis minor medially, long thoracic and lateral thoracic nerves were preserved intercostobrachial nerve wasn't preserved in all cases.
Data collection
The collected data was properly analyzed using the proper statistical methods in SPSS 21 package.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARM preservation ALND | Active Comparator | ARM +ve LN PRESERVED , ALND COMPLETED LATER ON |
|
| conventional ALND | Active Comparator | ARM +VE NODES MARKED AND TAKEN WITH ALND |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXILLARY REVERSE MAPPING | Procedure | subcutaneous injection of 1to 2 ml methylene blue 15 minutes before the procedure, identification of blue LN and lymphatic vessels |
|
| Measure | Description | Time Frame |
|---|---|---|
| histopathologic examination of ARM +ve LN | EITHER +VE OR -VE | IMMEDIATE POSTOPERATIVE |
| ARM LYMPHOEDEMA | INCREASE OF THE ARM VOLUME BY 10% | 2 years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| restriction of shoulder movement | in comparison to the other side | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
female , early breast cancer
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| hazem nour, MD | assistant professor, general surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig Faculty of Medicine | Zagazig | Sharqya | 44519 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2 groups of patients each 37 patient with early breast cancer one underwent ARM +ve LN biopsy with ALND, the other underwent ARM+ve LN preservation with completion of ALND
Not provided
Not provided
Not provided
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided