Lymphovenous Bypass Procedure for Breast Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Anticoagulants
Disqualifiers: Pregnancy, BMI over 50, others
No Placebo Group
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?This trial studies whether a surgical procedure called lymphovenous bypass can prevent arm swelling in patients with certain types of breast cancer or melanoma. The surgery creates a new path for fluid to move away from the arms, which may help stop swelling before it starts. Lymphovenous bypass is a surgical procedure that has been used to treat lymphedema by creating a new pathway for lymphatic fluid to drain, potentially reducing swelling.
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.
How is the Lymphovenous Bypass treatment different from other treatments for breast cancer-related lymphedema?
Lymphovenous Bypass (LVA) is a unique microsurgical procedure that connects tiny lymphatic vessels to small veins, helping to reduce lymphedema (swelling due to lymph fluid buildup) by improving lymphatic drainage. Unlike other treatments, it uses advanced techniques like dynamic ultrasonography to enhance the effectiveness of the procedure by identifying the best vessels for connection.
12345Eligibility Criteria
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.
+1 more
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.
+1 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group I (LVB)Experimental Treatment3 Interventions
Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND.
Group II: Group II (no intervention)Active Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
Loading ...
Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
The dynamic-lymphaticovenular anastomosis method for breast cancer treatment-related lymphedema: Creation of functional lymphaticovenular anastomoses with use of preoperative dynamic ultrasonography. [2019]Lymphaticovenular anastomosis (LVA) is generally an effective procedure for breast cancer treatment-related upper extremity lymphedema (UEL). Clinical improvement is, however, limited by the degree of sclerosis of the lymphatic vessels. We have developed a method by which we use dynamic ultrasonography to depict vessels through which lymph can be propelled into the LVA under the power of the patient's natural hand movements.
Patent blue dye in lymphaticovenular anastomosis. [2020]Lymphaticovenular anastomosis (LVA) has been described as a treatment of chronic lymphoedema. This microsurgical technique is new and technically difficult. The small caliber and thin wall lymphatic vessels are difficult to identify and easily destroyed during the dissection.
Peri-operative care for patients undergoing lymphaticovenular anastomosis: A systematic review. [2018]Lymphaticovenular anastomosis (LVA) is a supermicrosurgical procedure that involves the anastomosis of a functional lymphatic channel to a venule. Although peri-operative care might be an important contributor to the success of this technique, evidence about optimal peri-operative care seems limited. This review aims to summarize the peri-operative methods used by authors reporting on LVA.
Outcomes of Lymphovenous Anastomosis for Lower Extremity Lymphedema: A Systematic Review. [2022]Lymphovenous anastomosis (LVA) is a microsurgical treatment for lymphedema of the lower extremity (LEL). This study systematically reviews the most recent data on outcomes of various LVA techniques for LEL in diverse patients.
Evaluation of patency rates of different lymphaticovenous anastomosis techniques and risk factors for obstruction in secondary upper extremity lymphedema. [2020]Lymphaticovenous anastomosis (LVA) is one of the surgical treatments for lymphedema. Lymphaticovenous side-to-end anastomosis (LVSEA) and lymphaticovenous end-to-end anastomosis (LVEEA) are the most commonly used procedures; however, only a few reports have evaluated direct anastomosis. We used indocyanine green fluorescence lymphography to evaluate and to compare both techniques.