Early Breast Cancer Clinical Trial
Official title:
Evaluation of Axillary Reverse Mapping (ARM) in Clinically Axillary Node Negative Breast Cancer Patients
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
- Preoperative data including demographic criteria, histopathological findings of breast
biopsy and SLNB, preoperative measurement of arm volume by water displacement,
circumferential measurement of the arm at the metacarpopharyngeal level, wrist level, 10
cm and 15 cm distal and proximal to the lateral epicondyle respectively.
- State of ARM positive or negative
- Follow up was carried out on outpatient clinic basis, monthly in the first 6 months then
every 3 months for 2 years for data collection and later dates for regular follow up.
Data was recorded including ARM histopathology (considered as the primary outcome),
development of lymphedema defined as increase in arm volume by 10 % of the original
size, tingling, numbness, paraesthesia and restricted shoulder movement were considered
secondary outcome. Shoulder movement restriction was calculated by decrease of abduction
by 10 degrees in comparison to the contralateral arm, development of local axillary
recurrences, arm volume was measured at 6,12 and 24 months by water displacement method.
The collected data was properly analyzed using the proper statistical methods in SPSS 21
package.
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