Surgical Technique for Preventing Lymphedema After Breast Cancer Surgery

Recruiting at 1 trial location

Overseen By Sheri Ramaker, R.N.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Prior axillary dissection, radiation, lymphedema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Surgery and immediate post-operative period

264 Participants Needed

Trial Summary

What is the purpose of this trial?

The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.

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 data supports the effectiveness of the treatment for preventing lymphedema after breast cancer surgery?

Research suggests that immediate lymphovenous anastomosis (LVA) can reduce the risk of lymphedema by up to 30% after axillary lymph node dissection (ALND) by restoring lymphatic drainage. Additionally, immediate lymphatic reconstruction (ILR) has been shown to decrease postoperative drainage, which may help prevent lymphedema. ^{1 2 3 4 5}

Is the surgical technique for preventing lymphedema after breast cancer surgery safe?

The surgical techniques, including lymphovenous anastomosis (LVA) and lymphatic reconstruction, are being studied for safety. While they aim to reduce lymphedema risk, concerns about oncologic safety, such as the potential spread of cancer cells, are still being evaluated. Complications are not well-documented, but ongoing studies are assessing these procedures' safety. ^{1 6 7 8 9}

How does the treatment for preventing lymphedema after breast cancer surgery differ from other treatments?

This treatment is unique because it combines axillary reverse mapping (ARM) and lymphaticovenous bypass (LVB) to enhance lymphatic visualization and restore lymphatic flow, potentially reducing the risk of lymphedema after axillary lymph node dissection (ALND). This approach is different from standard treatments as it focuses on immediate surgical techniques to prevent lymphedema rather than managing it after it occurs. ^{1 2 3 10 11}

Research Team

James W Jakub

Principal Investigator

Mayo Clinic

Mara Piltin, DO

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

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

My surgeon thinks I might need a more extensive lymph node surgery based on what is found during surgery.

I am scheduled for surgery to remove lymph nodes under my arm.

Exclusion Criteria

I am having a minor lymph node surgery or my doctor thinks it's unlikely I'll need a more extensive one.

I have been treated or am being treated to prevent swelling in my arm(s).

I have had radiation therapy on the same side as my underarm before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

All subjects undergo axillary lymph node dissection (ALND), with some receiving axillary reverse mapping (ARM) and lympho-venous bypass (LVB)

Surgery and immediate post-operative period

Follow-up

Participants are monitored for limb volume and symptoms of lymphedema at 6, 12, 24, and 36 months after surgery

36 months

4 visits (in-person)

Treatment Details

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.

Participant Groups

Group I: ALND with ARM +/- LVB Experimental Treatment 1 Intervention

Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed.

Group II: ALND without ARM +/- LVB Active Control 1 Intervention

Axillary Lymph Node Dissection (ALND)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Incorporating Lymphovenous Anastomosis in Clinically Node-Positive Women Receiving Neoadjuvant Chemotherapy: A Shared Decision-Making Model and Nuanced Approached to the Axilla. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

The effect of immediate lymphatic reconstruction on the post-operative drain output after axillary lymph node dissection for breast cancer: A retrospective comparative study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Combined Surgical Treatment in Breast Cancer-Related Lymphedema. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Elective Hand Surgery in Patients With History of Axillary Node Dissection: Risks and Patient Education. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Immediate-delayed lymphatic reconstruction after axillary lymph nodes dissection for locally advanced breast cancer-related lymphedema prevention: Report of two cases. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Is Immediate Lymphatic Reconstruction on Breast Cancer Patients Oncologically Safe? A Preliminary Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

National Outcomes of Prophylactic Lymphovenous Bypass during Axillary Lymph Node Dissection. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Immediate Lymphatic Reconstruction during Axillary Node Dissection for Breast Cancer: A Systematic Review and Meta-analysis. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluation of axillary reverse mapping (ARM) in clinically axillary node negative breast cancer patients - Randomised controlled trial. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Axillary reverse mapping and lymphaticovenous bypass: Lymphedema prevention through enhanced lymphatic visualization and restoration of flow. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Lymphedema prevention and immediate breast reconstruction with simultaneous gastroepiploic vascularized lymph node transfer and deep inferior epigastric perforator flap: A case report. [2022]