Breast cancer breast cancer, axillary lymph node dissection, lymphedema, image-guided surgery, axillary reverse mappinga
Conditions
Interventions
Off-label use of ICG
indocyanine green
indocyanine green, off-label use
Sponsors
Nagayasu Takeshi
Otsubo Ryota
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age: over 20 year-old at an informed consent 2. gender: unmentioned 3. patients diagnosed as positive in axillary lymph nodes before surgery and positive in sentinel lymph nodes during surgery 4. Neoadjuvant chemotherapy: unmentioned 5. patients with a witten informed consent and good comprehension after enough explanation about this study
Exclusion criteria
Exclusion criteria: 1. patients who had developed lymph edema before surgery 2. patients with severe liver dysfunction 3. patients with past history of allergy for the indocyanine green and iodine 4. pregnent patients 5. patients who undergo bilateral axillary lymph node dissection 6. other patients who were judged as inappropriate by the chief physician for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. incidence of lymphedema after induction of ARM compared with that before induction of ARM 2. evaluation of adverse events in CTCAE 5.0 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. successful detecting rate of lymph ducts 2. number, diameter, intensity, and pattern of connection in lymph ducts 3. incidence of recurrence in axillary lymph nodes | — |
Contacts
Public ContactRyota Otsubo
Nagasaki University Hospital
Outcome results
None listed