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

NCT04137744 | Completed DMC

• 1 other identifier: hazem nour
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

axillary reverse mapping; arm lymphedema; early breast cancer

Outcome Measures

Primary Outcomes (2)

• histopathologic examination of ARM +ve LN

  EITHER +VE OR -VE

  IMMEDIATE POSTOPERATIVE

• ARM LYMPHOEDEMA

  INCREASE OF THE ARM VOLUME BY 10%

  2 years postoperative

Secondary Outcomes (1)

• restriction of shoulder movement

  2 years

Study Arms (2)

ARM preservation ALND

ACTIVE COMPARATOR

ARM +ve LN PRESERVED , ALND COMPLETED LATER ON

Procedure: AXILLARY REVERSE MAPPING

conventional ALND

ACTIVE COMPARATOR

ARM +VE NODES MARKED AND TAKEN WITH ALND

Procedure: AXILLARY REVERSE MAPPING

Interventions

AXILLARY REVERSE MAPPING PROCEDURE

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

Also known as: ALND, axillary lymph node dissection

ARM preservation ALND; conventional ALND

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female , early breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinically free breast cancer
• sentinle LN positive

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig Faculty of Medicine

Zagazig, Sharqya, 44519, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• hazem nour, MD

  assistant professor, general surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 24, 2019
• Study Start: February 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: November 6, 2019

Record last verified: 2019-11

Locations

EG (1)