Lymphovenous Bypass Procedure before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients with Inflammatory or Locally Advanced Non-inflammatory Breast Cancer
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Texas
Houston
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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 Phase NA
Trial Type Prevention
Lead Organization
M D Anderson Cancer Center
Principal Investigator
Mark Schaverien
- Primary ID 2018-0127
- Secondary IDs NCI-2019-02320
- Clinicaltrials.gov ID NCT03941756