Axillary Reverse Mapping Using Methylene Blue Subcutaneous Injection Can Identify Arm Lymph Nodes and Vessels, Measuring Arm Size for Lymphedema, Histopathological Examination of Arm Lymph Nodes Included With Axillary Lymph Node Dissection

NCT ID: NCT04137744

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2019-08-31

Brief Summary

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

Detailed Description

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.

Conditions

Arm Lymphedema; Lymphatic Spread of Breast Cancer; Early Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

ARM preservation ALND

ARM +ve LN PRESERVED , ALND COMPLETED LATER ON

Group Type: ACTIVE_COMPARATOR

AXILLARY REVERSE MAPPING

Intervention Type: PROCEDURE

subcutaneous injection of 1to 2 ml methylene blue 15 minutes before the procedure, identification of blue LN and lymphatic vessels

conventional ALND

ARM +VE NODES MARKED AND TAKEN WITH ALND

Group Type: ACTIVE_COMPARATOR

AXILLARY REVERSE MAPPING

Intervention Type: PROCEDURE

subcutaneous injection of 1to 2 ml methylene blue 15 minutes before the procedure, identification of blue LN and lymphatic vessels

Interventions

AXILLARY REVERSE MAPPING

subcutaneous injection of 1to 2 ml methylene blue 15 minutes before the procedure, identification of blue LN and lymphatic vessels

Intervention Type: PROCEDURE

Other Intervention Names

ALND; axillary lymph node dissection

Eligibility Criteria

Inclusion Criteria

• clinically free breast cancer
• sentinle LN positive

Exclusion Criteria

• patients on chemotherapy for breast cancer
• recurrent cases after conservative breast surgery
• bilateral disease and pregnant cases

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hazem Nour Abdellatif

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hazem nour, MD

Role: PRINCIPAL_INVESTIGATOR

assistant professor, general surgery

Locations

Zagazig Faculty of Medicine

Zagazig, Sharqya, Egypt

Countries

Egypt

Other Identifiers

hazem nour

Identifier Type: -

Identifier Source: org_study_id