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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lymphovenous bypass (LVB) can prevent lymphedema (swelling due to fluid build-up) when performed during skin cancer surgery, rather than after lymphedema develops. Participants will be divided into two groups based on the location of their surgery, either the upper or lower body. This trial targets individuals with melanoma who are scheduled for specific surgeries called ALND or ILND. Those diagnosed with melanoma and preparing for one of these surgeries might be suitable candidates for this study. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

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 prior data suggests that Lymphovenous Bypass is safe for preventing lymphedema?

Research has shown that lymphovenous bypass (LVB) is generally safe and well-tolerated. In one study, only 5.2% of patients experienced a recurrence of melanoma. Another study found that 83% of patients had reduced swelling from lymphedema (a condition where fluid builds up and causes swelling) after six months. Additional research indicates that 90% of patients saw improvements in symptoms such as skin hardness and swelling. These findings suggest that LVB is safe and can effectively alleviate lymphedema symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lymphovenous bypass (LVB) technique for skin cancer because it offers a novel way to prevent lymphedema, a common side effect of cancer surgeries that remove lymph nodes. Unlike traditional treatments that focus on managing lymphedema after it develops, LVB aims to prevent it by rerouting lymphatic fluid into nearby veins, potentially reducing swelling and improving quality of life. This forward-thinking approach could offer skin cancer patients a proactive solution, setting it apart from current options that mainly provide reactive care.

What evidence suggests that Lymphovenous Bypass is effective for preventing lymphedema in skin cancer patients?

Research has shown that Lymphovenous Bypass (LVB) can effectively treat lymphedema, which is swelling caused by a buildup of lymph fluid. Studies found that after the surgery, the size of the swollen limb decreased by about 44.68%. In most cases, 63% of patients no longer needed extra therapy. This trial will divide participants into two groups: one receiving LVB for the lower extremity and another for the upper extremity. For both arms and legs, 83% of patients reported feeling better six months after LVB, indicating that LVB can significantly reduce swelling and improve quality of life. ^{5 6 7 8 9}

Who Is on the Research Team?

Ashleigh M Francis, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7139674/

Systematic Review of Patient-Reported Outcomes ... Average follow up for lower extremity patients was 18.2 months and 57% noted symptomatic improvement. Poumellec et al. reported that at 12.7 ...

2. withpower.com withpower.com/trial/phase-lymphadenectomy-8-2025-6a113

Lymphovenous Bypass for Skin Cancer · Info for Participants 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0890509622002242

A Meta-analysis of 37 Studies on the Effectiveness ... The affected limb circumference was reduced by approximately, 44.68% after the microsurgery. After the microsurgery, 63% of the patients did not need ...

4. link.springer.com link.springer.com/article/10.1007/s00238-025-02330-5

Investigating the oncological impact of immediate ... Limited, low-quality data suggests prophylactic post-inguinal LVA may be associated with reduced overall survival and increased recurrence and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4365441/

Lymphaticovenous Bypass Decreases Pathologic Skin ... Six months following LVB, 83% of patients had symptomatic improvement in their lymphedema. Histological analysis at this time demonstrated a significant ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10566866/

Safety and Efficacy of Immediate Lymphatic Reconstruction in ... Follow-up length ranged from 6 to 67 months. Melanoma recurred in 40.7% of the intervention group versus 52.1% in the control group (p=0.067). 5.2% developed ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03941756

Study Details | NCT03941756 | Lymphovenous Bypass ... This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or ...

8. researchgate.net researchgate.net/publication/374987924_Safety_and_Efficacy_of_Immediate_Lymphatic_Reconstruction_in_Patients_with_Melanoma_A_Systematic_Review

Safety and Efficacy of Immediate Lymphatic Reconstruction ... Comparative studies on LVB at the time of inguinal lymph node dissection identified an incidence of lymphedema at 8.3% with ILR compared to ...

9. mdpi.com mdpi.com/2072-6694/12/3/565

Systematic Review of Patient-Reported Outcomes ... At 18 months follow up, 9 of 10 (90%) patients reported noticeable improvements in their symptoms (skin induration, sensation of swelling, worsening in the ...