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Impact of the ARM Technique on the Prevention of Lymphedema After Axillary Lymphadenectomy: A Multicenter Randomized Clinical Trial

NCT07515300 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-04-07

No results posted yet for this study

Summary

To evaluate the reduction of secondary lymphedema following axillary lymphadenectomy by incorporating the ARM technique during the procedure, without negatively impacting patient prognosis.

Conditions

Interventions

PROCEDURE

Axillary Reverse Mapping

During axillary lymphadenectomy, the ARM technique will be incorporated. Prior to surgery, periareolar Tc99 injection will be performed to identify breast sentinel lymph nodes. Fifteen minutes before surgery, 2 mL of indocyanine green tracer will be injected subcutaneously in the medial intermuscular region of the ipsilateral upper limb, followed by gentle massage for 5 minutes. Standard axillary lymphadenectomy will then be performed, preserving ARM lymph nodes located below the axillary vein and lateral to the thoracodorsal pedicle.

Sponsors & Collaborators

  • Hospital Universitari de Bellvitge

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07515300 on ClinicalTrials.gov