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Preventing lymphedema in breast cancer surgery: a study using fluorescent imaging to identify lymphatic vessels and microsurgery to join them to veins during lymph node removal

Effect of immediate lymphaticovenous anastomosis with indocyanine green fluorescence reverse mapping during axillary lymph node dissection for breast cancer

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000414415
Enrollment
100
Registered
2025-05-07
Start date
2026-04-01
Completion date
2027-06-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate a new technique, immediate lymphaticovenous anastomosis (ILA), to preserve lymphatic drainage and prevent the development of breast cancer–related lymphedema. Who is it for? You may be eligible for this study if you are a female diagnosed with breast cancer and require axillary lymph node dissection (ALND). Study details During ALND, a fluorescent dye will be used to map the lymphatic vessels, which will then be joined to adjacent veins under high magnification using supermicrosurgical techniques. Follow-up data on the incidence of post-operative breast cancer–related lymphedema and any other surgical complications will be collected up to 12 months post-operatively. It is hoped that findings from this study will help identify new methods to manage the incidence of breast cancer–related lymphedema in those undergoing axillary lymph node dissection.

Interventions

The intervention involves performing immediate lymphaticovenous anastomosis (ILA) at the time of axillary lymph node dissection (ALND) for breast cancer. Indocyanine green (ICG) fluorescence axillary reverse mapping (ARM) is used intraoperatively to identify lymphatic vessels draining the upper limb. ICG (2.5 mg/mL) is injected intradermally into the upper inner arm, and a near-infrared fluorescence imaging system is used to visualize the lymphatic channels. Identified lymphatic vessels are pres

The intervention involves performing immediate lymphaticovenous anastomosis (ILA) at the time of axillary lymph node dissection (ALND) for breast cancer. Indocyanine green (ICG) fluorescence axillary reverse mapping (ARM) is used intraoperatively to identify lymphatic vessels draining the upper limb. ICG (2.5 mg/mL) is injected intradermally into the upper inner arm, and a near-infrared fluorescence imaging system is used to visualize the lymphatic channels. Identified lymphatic vessels are preserved and anastomosed to adjacent veins using supermicrosurgical techniques under high magnification. The procedure is performed by a trained plastic and reconstructive surgeon. The intervention is typically completed within 45 to 60 minutes. Adherence to the intervention is monitored and documented in the operative report, including details of lymphatic identification and the number of anastomoses performed. No additional lymphedema-specific therapies are administered postoperatively.

Sponsors

Chris O'Brien Lifehouse
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Female patients aged 18 years or older • Diagnosis of breast cancer requiring axillary lymph node dissection (ALND) • Willing and able to provide informed consent • Planned surgery to be performed at the participating institution

Exclusion criteria

• Pre-existing ipsilateral lymphedema • Known allergy or hypersensitivity to indocyanine green (ICG) • Iodine allergy • Chronic kidney disease stage 3, 4, or 5 • Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Apr 4, 2026