Surgical Technique for Preventing Lymphedema After Breast Cancer Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a special surgical technique can prevent lymphedema, a condition where excess fluid causes swelling, after breast cancer surgery. Researchers are testing whether axillary reverse mapping (ARM) and lympho-venous bypass (LVB) during axillary lymph node dissection (ALND) can help reduce swelling. Participants are divided into two groups: one will undergo surgery with ARM and LVB, while the other will have surgery without these techniques. This trial targets patients scheduled for lymph node removal who are at high risk for requiring this procedure during surgery. As an unphased trial, it offers patients the chance to contribute to innovative surgical techniques that could improve post-surgery outcomes.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this surgical technique is safe for preventing lymphedema after breast cancer surgery?
Research has shown that adding axillary reverse mapping (ARM) and lympho-venous bypass (LVB) to axillary lymph node dissection (ALND) is safe. Studies have found that ARM significantly reduces the risk of lymphedema, which is swelling caused by a build-up of lymph fluid, after breast cancer surgery. Notably, the chance of cancer spreading to lymph nodes identified by ARM remains low, indicating that this method does not compromise safety.
These techniques have been used together for several years, with evidence supporting their effectiveness in reducing lymphedema without introducing significant risks. This can reassure patients considering these procedures as part of their treatment plan.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a new surgical technique aimed at preventing lymphedema after breast cancer surgery. Unlike standard procedures that involve axillary lymph node dissection (ALND) alone, this approach uses Axillary Reverse Mapping (ARM) combined with a lympho-venous bypass (LVB). ARM helps identify and preserve lymphatic channels, potentially reducing the risk of lymphedema. The addition of LVB further enhances this technique by rerouting lymphatic fluid directly into the venous system, offering a more comprehensive strategy to maintain normal lymphatic function. This combination could significantly improve post-surgical outcomes for breast cancer patients.
What evidence suggests that this surgical technique is effective for preventing lymphedema?
This trial will compare two surgical techniques for preventing lymphedema after breast cancer surgery. One group of participants will undergo Axillary Lymph Node Dissection (ALND) with Axillary Reverse Mapping (ARM) and possibly Lympho-venous Bypass (LVB). Research has shown that ARM with LVB during axillary lymph node removal can help prevent lymphedema. Studies have found that ARM can identify and protect the lymph vessels that drain fluid from the arm, reducing the risk of lymphedema. Specifically, patients who underwent ARM during their surgery experienced less swelling over time compared to those who did not. This method focuses on preserving important lymph nodes, maintaining normal fluid flow, and reducing swelling. Overall, ARM with LVB shows promise in reducing the chances of lymphedema after surgery.36789
Who Is on the Research Team?
James W Jakub
Principal Investigator
Mayo Clinic
Mara Piltin, DO
Principal Investigator
Mayo Clinic in Rochester
Are You a Good Fit for This Trial?
This trial is for English-speaking patients at high risk of needing axillary lymph node dissection (ALND) as judged by their surgeon. It's not for those who've had radiation in the same armpit area, only need a sentinel lymph node biopsy, have been treated or are being treated to prevent arm lymphedema, or are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
All subjects undergo axillary lymph node dissection (ALND), with some receiving axillary reverse mapping (ARM) and lympho-venous bypass (LVB)
Follow-up
Participants are monitored for limb volume and symptoms of lymphedema at 6, 12, 24, and 36 months after surgery
What Are the Treatments Tested in This Trial?
Interventions
- ALND
- ALND with ARM +/- LVB
Trial Overview
The study aims to see if adding axillary reverse mapping (ARM) and lympho-venous bypass (LVB) when performing ALND can reduce the chances and severity of developing arm lymphedema after surgery in breast cancer and melanoma patients.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.
Axillary Lymph Node Dissection (ALND)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
The effectiveness of axillary reverse mapping in preventing ...
ARM during ALND can prevent and reduce the occurrence of BCRL in patients with early-stage BC during long-term follow-up.
Study Details | NCT03927027 | Axillary Reverse Mapping ...
This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node ...
Prevention of lymphedema via axillary reverse mapping for ...
In the current study, our objectives were to assess the effectiveness of arm-node preservation by ARM for prevention of lymphedema in patients ...
Clinical application of axillary reverse mapping in patients ...
The efficacy of arm node preserving surgery using axillary reverse mapping for preventing lymphedema in patients with breast cancer. Journal of Breast Cancer ...
5.
acsjournals.onlinelibrary.wiley.com
acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.34498Occurrence of breast‐cancer–related lymphedema after ...
Axillary reverse mapping (ARM) can identify the lymphatics draining the arm, enabling the selective sparing of axillary lymph nodes to reduce ...
Clinical application of axillary reverse mapping in patients with ...
ARM was found to significantly reduce the incidence of BCRL. The selection of patients for this procedure should be based on their axillary nodal status.
Axillary Reverse Mapping: Five Year Experience - PMC
Metastases in ARM-identified lymph nodes were acceptably low indicating that ARM is safe. ARM added to present-day ALND and SLNB may be useful to lower ...
Immediate lymphatic reconstruction for breast cancer ...
This systematic review revealed an overall relative risk (RR) of 0.51 of developing BCRL in patients receiving ILR after axillary lymph node dissection. The RR ...
9.
southcarolinablues.com
southcarolinablues.com/web/public/brands/medicalpolicyih/external-policies/axillary-reverse-mapping-for-breast-cancer-related-lymphedema/Axillary Reverse Mapping for Breast Cancer-Related ...
Axillary reverse mapping, also called reverse lymphatic mapping, has been developed with the intent of sparing axillary lymph nodes and lymphatics during breast ...
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