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
Primary Purpose
Arm Lymphedema, Lymphatic Spread of Breast Cancer, Early Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
AXILLARY REVERSE MAPPING
Sponsored by
About this trial
This is an interventional screening trial for Arm Lymphedema focused on measuring axillary reverse mapping, arm lymphedema, early breast cancer
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
Sites / Locations
- Zagazig Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
ARM preservation ALND
conventional ALND
Arm Description
ARM +ve LN PRESERVED , ALND COMPLETED LATER ON
ARM +VE NODES MARKED AND TAKEN WITH ALND
Outcomes
Primary Outcome Measures
histopathologic examination of ARM +ve LN
EITHER +VE OR -VE
ARM LYMPHOEDEMA
INCREASE OF THE ARM VOLUME BY 10%
Secondary Outcome Measures
restriction of shoulder movement
in comparison to the other side
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04137744
Brief Title
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
Official Title
Evaluation of Axillary Reverse Mapping (ARM) in Clinically Axillary Node Negative Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arm Lymphedema, Lymphatic Spread of Breast Cancer, Early Breast Cancer
Keywords
axillary reverse mapping, arm lymphedema, early breast cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARM preservation ALND
Arm Type
Active Comparator
Arm Description
ARM +ve LN PRESERVED , ALND COMPLETED LATER ON
Arm Title
conventional ALND
Arm Type
Active Comparator
Arm Description
ARM +VE NODES MARKED AND TAKEN WITH ALND
Intervention Type
Procedure
Intervention Name(s)
AXILLARY REVERSE MAPPING
Other Intervention Name(s)
ALND, axillary lymph node dissection
Intervention Description
subcutaneous injection of 1to 2 ml methylene blue 15 minutes before the procedure, identification of blue LN and lymphatic vessels
Primary Outcome Measure Information:
Title
histopathologic examination of ARM +ve LN
Description
EITHER +VE OR -VE
Time Frame
IMMEDIATE POSTOPERATIVE
Title
ARM LYMPHOEDEMA
Description
INCREASE OF THE ARM VOLUME BY 10%
Time Frame
2 years postoperative
Secondary Outcome Measure Information:
Title
restriction of shoulder movement
Description
in comparison to the other side
Time Frame
2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female , early breast cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hazem nour, MD
Organizational Affiliation
assistant professor, general surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig Faculty of Medicine
City
Zagazig
State/Province
Sharqya
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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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
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