Lymphovenous Bypass Procedure for Breast Cancer

Overseen By Mark Schaverien

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)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

252 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether lymphovenous bypass surgery can prevent arm swelling (lymphedema) in individuals with certain types of breast cancer or melanoma. The procedure creates a new path for fluid to flow away from the arms, potentially preventing swelling. Participants will either receive the surgery during their lymph node removal or not receive any intervention. Those with inflammatory or advanced non-inflammatory breast cancer undergoing lymph node surgery with expected radiation, or those with melanoma undergoing lymph node surgery, might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could benefit 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 the surgery.

What prior data suggests that the lymphovenous bypass procedure is safe for preventing lymphedema?

Research has shown that the lymphovenous bypass procedure is generally safe and well-tolerated. This procedure often helps reduce arm swelling (lymphedema) after breast cancer treatment. Studies have found it does not lead to more surgeries or wound problems. For example, one study reported positive results in almost all cases, with many patients experiencing a significant decrease in arm swelling. Another study confirmed the procedure's safety, noting a low risk of complications. Overall, evidence suggests that lymphovenous bypass is a reliable option for managing or preventing lymphedema with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Lymphovenous Bypass (LVB) is unique because it specifically targets lymphatic drainage issues that can occur after breast cancer surgery. Unlike traditional treatments that often focus on managing symptoms of lymphedema, LVB aims to prevent or significantly reduce the condition by creating new pathways for lymph fluid to drain, thereby addressing the root cause of the problem. Researchers are excited about this technique because it offers a proactive approach to managing post-surgical lymphedema, potentially improving quality of life and reducing the need for long-term management strategies like compression garments or physical therapy.

What evidence suggests that the lymphovenous bypass procedure is effective for preventing lymphedema in breast cancer patients?

Research has shown that lymphovenous bypass (LVB), which participants in this trial may undergo, can help reduce arm swelling, known as lymphedema, after breast cancer surgery. One study found that patients who underwent this procedure saw their arm size decrease by about 30% on average, and most reported feeling better afterward. Another study found that LVB is safe and can reduce the risk of developing lymphedema when combined with lymph node surgery. These findings suggest that LVB might help prevent or lessen arm swelling for breast cancer patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Mark Schaverien

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with inflammatory or locally advanced non-inflammatory breast cancer, planning to have underarm lymph node surgery and radiation therapy. It's not for pregnant individuals, those unable to follow up for at least 18 months, patients on anticoagulants within a week of surgery, or with a BMI over 50.

Inclusion Criteria

Patients willing to participate

Patients able to complete informed consent

You have inflammatory breast cancer, or non-inflammatory breast cancer that is being treated with ALND and radiation therapy.

Exclusion Criteria

Patients that are known to be pregnant at the time of surgery

Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period

You have taken blood thinners within 7 days before surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Follow-up visits at 2 weeks, 6 months, 12 months, and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Lymphovenous Bypass

Trial Overview The study tests if the lymphovenous bypass procedure can prevent arm swelling (lymphedema) when done before underarm lymph node surgery in breast cancer patients. Lymphangiography and Indocyanine Green are used to help perform this preventive measure.

How Is the Trial Designed?

Group I: Group I (LVB) Experimental Treatment 3 Interventions

Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.

Group II: Group II (no intervention) Active Control 1 Intervention

Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.

Lymphovenous Bypass is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Lymphovenous Bypass for:

• Prevention of lymphedema in patients with inflammatory or locally advanced non-inflammatory breast cancer or melanoma

Approved in European Union as Lymphovenous Bypass for:

• Treatment of lymphedema in patients with breast cancer or melanoma

Approved in Canada as Lymphovenous Bypass for:

• Prevention and treatment of lymphedema in patients with breast cancer or melanoma

Approved in Japan as Lymphovenous Bypass for:

• Treatment of lymphedema in patients with breast cancer or melanoma

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Dynamic lymphaticovenular anastomosis (LVA) significantly improves clinical outcomes for patients with breast cancer-related upper extremity lymphedema compared to conventional LVA, with greater postoperative volume reduction observed at both 1 month and 1 year.

The use of dynamic ultrasonography in the dynamic LVA method allows for better incision placement by visualizing lymphatic vessels, leading to fewer sclerotic vessels encountered and enhancing the effectiveness of lymph propulsion during natural hand movements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The dynamic-lymphaticovenular anastomosis method for breast cancer treatment-related lymphedema: Creation of functional lymphaticovenular anastomoses with use of preoperative dynamic ultrasonography. Seki, Y., Kajikawa, A., Yamamoto, T., et al.[2019]

A systematic review of 22 studies on lymphaticovenular anastomosis (LVA) found that while peri-operative care is crucial, the quality of evidence is low and descriptions of management practices are often sparse.

The preferred peri-operative care includes the use of prophylactic antibiotics, limb elevation during recovery, and starting compression therapy 4 weeks post-surgery, but more detailed protocols are needed for better comparison and optimization of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peri-operative care for patients undergoing lymphaticovenular anastomosis: A systematic review. Winters, H., Tielemans, HJ., Sprangers, PN., et al.[2018]

In a study of 18 patients with secondary upper extremity lymphedema, both lymphaticovenous side-to-end anastomosis (LVSEA) and end-to-end anastomosis (LVEEA) showed similar low patency rates, with 32% and 35% respectively being patent after 6 months.

The study suggests that LVSEA may be the preferred technique for lymphaticovenous anastomosis due to a lower likelihood of lymphatic obstruction compared to LVEEA, especially in cases where the risk of obstruction is a concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of patency rates of different lymphaticovenous anastomosis techniques and risk factors for obstruction in secondary upper extremity lymphedema. Suzuki, Y., Sakuma, H., Yamazaki, S.[2020]

Using patent blue dye to enhance lymphaticovenular anastomosis (LVA) allows for better identification of lymphatic vessels, making the microsurgical procedure easier and safer for patients with chronic lymphoedema.

The technique not only aids in the dissection of lymphatic vessels but also confirms the success of the anastomosis by visualizing the dynamic pumping action of the lymphatics, demonstrating its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patent blue dye in lymphaticovenular anastomosis. Yap, YL., Lim, J., Shim, TW., et al.[2020]

Lymphovenous anastomosis (LVA) is a safe and effective microsurgical treatment for lymphedema of the lower extremity, showing objective improvement rates ranging from 23.3% to 100% across various patients, particularly benefiting those with early-stage lymphedema.

The study reviewed 74 articles involving 6260 patients, indicating that LVA can significantly enhance quality of life and reduce lymphedema symptoms, with emerging techniques potentially leading to even better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Lymphovenous Anastomosis for Lower Extremity Lymphedema: A Systematic Review. Verhey, EM., Kandi, LA., Lee, YS., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7225471/

Lymphaticovenular anastomosis for breast cancer-related ... Outcomes were positive in 21 of 22 studies, with an average objective regression of arm volume around 30%. Subjective clinical improvement was nearly universal, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681525002852

Immediate lymphovenous anastomosis is effective in ... This study showed that ILA has a protective effect on BCRL rates in patients undergoing ALND. ILA has also been shown to be a safe procedure with low risk of ...

3. abs.amegroups.org abs.amegroups.org/article/view/7988/html

Lymphovenous bypass - Huang - Annals of Breast Surgery Clinical outcomes show that LVB is effective in both quantitative outcomes such as limb volume reduction as well as qualitative outcomes such as patient ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10431289/

Prophylactic Lymphovenous Bypass at the Time of Axillary ... Primary outcomes included early postoperative complications (within 30 days of surgery) and lymphedema development. A subanalysis of patients ...

5. nature.com nature.com/articles/s41598-024-52489-3

The 6 month interim analysis of a randomized controlled ... Lymphaticovenous anastomosis has shown promising results in alleviating physical symptoms and increasing quality of life in patients with BCRL.

6. profiles.wustl.edu profiles.wustl.edu/en/publications/national-outcomes-of-prophylactic-lymphovenous-bypass-during-axil

National Outcomes of Prophylactic Lymphovenous Bypass ... Prophylactic LVB at time of ALND is a generally safe and well-tolerated procedure and is not associated with increased reoperations or wound complications.