Lymphovenous Bypass Procedure before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients with Inflammatory or Locally Advanced Non-inflammatory Breast Cancer
This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.
- Patients willing to participate.
- Patients able to complete informed consent.
- Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy.
- Patients taking anticoagulants within 7 days prior to surgery.
- Patients that are known to be pregnant at the time of surgery.
- Patients are available for follow-up less than 18 months.
- Patients with known iodine hypersensitivity.
- Patients with known hypersensitivity to indocyanine green (ICG).
- Patients with body mass index (BMI) greater than 40.0.
Locations & Contacts
Contact: Mark Schaverien
Trial Objectives and Outline
I. To evaluate the protective benefit to performing lymphovenous bypass (LVB) surgery at the time of axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.
I. Compare the medical outcomes for patients receiving LVB surgery with those receiving standard surgery without the intervention.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND.
GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.
Trial Phase & Type
No phase specified
M D Anderson Cancer Center
Secondary IDs NCI-2019-02320
Clinicaltrials.gov ID NCT03941756