Lymphovenous Bypass for Skin Cancer

Overseen By Ashleigh M Francis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, BMI over 50, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking anticoagulants (blood thinners) at least 7 days before surgery.

What data supports the effectiveness of the treatment Lymphovenous Bypass (LVB) for skin cancer?

Lymphovenous Bypass (LVB) has been shown to be effective in treating lymphedema (swelling due to lymph fluid buildup) in patients with breast cancer and other conditions, with studies indicating it reduces the risk of lymphedema and has a low complication rate. ^{1 2 3 4 5}

How is the treatment Lymphovenous Bypass (LVB) unique for skin cancer?

Lymphovenous Bypass (LVB) is unique because it is a surgical procedure that connects lymphatic vessels to veins, helping to prevent or treat lymphedema (swelling due to lymph fluid buildup) often seen after lymph node removal in skin cancer patients. Unlike other treatments, LVB directly addresses the lymphatic system's drainage issues, offering a targeted approach with a low complication rate. ^{1 2 6 7 8}

What is the purpose of this trial?

To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.

Research Team

Ashleigh M Francis, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for melanoma patients who are undergoing lymphadenectomy, a surgery to remove lymph nodes. It aims to see if performing Lymphovenous bypass (LVB) during the surgery can prevent lymphedema, which is swelling due to lymph fluid buildup.

Inclusion Criteria

I can understand and agree to the study's requirements.

I am willing to participate in the clinical trial.

I am diagnosed with Melanoma and will have lymph node surgery.

Exclusion Criteria

Participants known to be pregnant at the time of surgery

My BMI is over 50.

I have taken blood thinners within a week before surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Lymphatic Reconstruction

Participants undergo lymphovenous bypass (LVB) at the time of axillary or inguinal lymph node dissection

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for wound complications and time to drain removal within the first 30 days post-surgery

4 weeks

Follow-up

Participants are monitored for lymphedema occurrence and quality of life at 3 months, 6 months, and 1 year post-surgery

1 year

Treatment Details

Interventions

• Lymphovenous Bypass (LVB)

Trial Overview The study tests whether immediate Lymphovenous bypass (LVB) during lymph node removal can prevent the onset of lymphedema in skin cancer patients, compared with standard care where LVB isn't performed immediately.

Participant Groups

Group I: Upper extremity group recieving ALND Experimental Treatment 1 Intervention

Participants will be recruited pre-operatively by their treating physicians.

Group II: Lower extremity group getting ILND Experimental Treatment 1 Intervention

Participants will be recruited pre-operatively by their treating physicians.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

References

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

Prophylactic Lymphovenous Bypass at the Time of Axillary Lymph Node Dissection Decreases Rates of Lymphedema. [2023]

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

Lymphovenous bypass for the treatment of lymphedema. [2018]

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

Physical and Functional Outcomes of Simultaneous Vascularized Lymph Node Transplant and Lymphovenous Bypass in the Treatment of Lymphedema. [2022]

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

Outcomes analysis of microsurgical physiologic lymphatic procedures for the upper extremity from the United States National Surgical Quality Improvement Program. [2022]

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

A prospective analysis of 100 consecutive lymphovenous bypass cases for treatment of extremity lymphedema. [2023]

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

Cost-Effectiveness Analysis: Lymph Node Transfer vs Lymphovenous Bypass for Breast Cancer-Related Lymphedema. [2021]

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

Combined Approach to Surgical Treatment of Lymphedema. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Immediate inguinal lymphaticovenous anastomosis following lymphadenectomy in skin cancer of lower extremities. [2022]