20 Participants Needed

Lymphovenous Bypass for Skin Cancer

AM
Overseen ByAshleigh M Francis, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.12678

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

AM

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
2Treatment groups
Experimental Treatment
Group I: Upper extremity group recieving ALNDExperimental Treatment1 Intervention
Participants will be recruited pre-operatively by their treating physicians.
Group II: Lower extremity group getting ILNDExperimental Treatment1 Intervention
Participants will be recruited pre-operatively by their treating physicians.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

References

Prophylactic Lymphovenous Bypass at the Time of Axillary Lymph Node Dissection Decreases Rates of Lymphedema. [2023]
Lymphovenous bypass for the treatment of lymphedema. [2018]
Physical and Functional Outcomes of Simultaneous Vascularized Lymph Node Transplant and Lymphovenous Bypass in the Treatment of Lymphedema. [2022]
Outcomes analysis of microsurgical physiologic lymphatic procedures for the upper extremity from the United States National Surgical Quality Improvement Program. [2022]
A prospective analysis of 100 consecutive lymphovenous bypass cases for treatment of extremity lymphedema. [2023]
Cost-Effectiveness Analysis: Lymph Node Transfer vs Lymphovenous Bypass for Breast Cancer-Related Lymphedema. [2021]
Combined Approach to Surgical Treatment of Lymphedema. [2021]
Immediate inguinal lymphaticovenous anastomosis following lymphadenectomy in skin cancer of lower extremities. [2022]
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