Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000414415p
Ethics application status
Submitted, not yet approved
Date submitted
13/04/2025
Date registered
7/05/2025
Date last updated
7/05/2025
Date data sharing statement initially provided
7/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
Effect of immediate lymphaticovenous anastomosis with indocyanine green fluorescence reverse mapping during axillary lymph node dissection for breast cancer
Secondary ID [1] 314200 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lymphedema 337096 0
Condition category
Condition code
Cancer 333513 333513 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330804 0
Treatment: Surgery
Comparator / control treatment
The control group consists of a retrospective cohort of breast cancer patients who underwent axillary lymph node dissection (ALND) between January 2022 and December 2024 at the same institution prior to the implementation of axillary reverse mapping and immediate lymphaticovenous anastomosis. These patients received standard-of-care treatment without any intraoperative lymphatic preservation or reconstruction techniques. Lymphedema status in the control group will be determined via a structured telephone survey and review of medical records, with diagnosis confirmed based on clinical symptoms and documentation of formal diagnosis by a healthcare provider.
Control group
Historical

Outcomes
Primary outcome [1] 341088 0
Incidence of breast cancer-related lymphedema (BCRL)
Timepoint [1] 341088 0
6 and 12 months postoperatively
Primary outcome [2] 341285 0
Incidence of breast cancer-related lymphedema (BCRL)
Timepoint [2] 341285 0
6 and 12 months postoperatively
Primary outcome [3] 341288 0
Incidence of breast cancer-related lymphedema (BCRL)
Timepoint [3] 341288 0
6 and 12 months postoperatively
Secondary outcome [1] 446184 0
Success rate of immediate lymphaticovenous anastomosis (ILA)
Timepoint [1] 446184 0
Intraoperative
Secondary outcome [2] 446185 0
Postoperative complications related to ILA (e.g., infection, seroma, delayed healing)
Timepoint [2] 446185 0
Up to 30 days postoperative

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The control group consists of a retrospective cohort of breast cancer patients who underwent axillary lymph node dissection (ALND) between January 2022 and December 2024 at the same institution, prior to the implementation of axillary reverse mapping and immediate lymphaticovenous anastomosis. These patients received standard-of-care treatment without any intraoperative lymphatic preservation or reconstruction techniques.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarize demographic and clinical characteristics. Continuous variables will be reported as mean ± standard deviation (SD) or median with interquartile range (IQR), depending on distribution. Categorical variables will be summarized as frequencies and percentages.

Comparisons between groups (intervention vs. control) will be performed using Chi-squared or Fisher’s exact tests for categorical variables, and Student’s t-test or Wilcoxon rank-sum test for continuous variables. A Cox proportional hazards model will be used to evaluate factors associated with lymphedema development over time. Variables with p = 0.2 in univariate analysis will be included in multivariate regression.

A p-value = 0.05 will be considered statistically significant. Statistical analyses will be performed using RStudio (version 2024.09.0).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2027
Actual
Date of last data collection
Anticipated
1/06/2028
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27773 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 43961 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 318717 0
Hospital
Name [1] 318717 0
Chris O'Brien Lifehouse
Country [1] 318717 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
Country
Australia
Secondary sponsor category [1] 321148 0
None
Name [1] 321148 0
Address [1] 321148 0
Country [1] 321148 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317328 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 317328 0
Ethics committee country [1] 317328 0
Australia
Date submitted for ethics approval [1] 317328 0
13/04/2025
Approval date [1] 317328 0
Ethics approval number [1] 317328 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140698 0
A/Prof Sanjay Warrier
Address 140698 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 140698 0
Australia
Phone 140698 0
+61 2 8514 0785
Fax 140698 0
Email 140698 0
[email protected]
Contact person for public queries
Name 140699 0
Chu Luan Nguyen
Address 140699 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 140699 0
Australia
Phone 140699 0
+61 2 8514 0785
Fax 140699 0
Email 140699 0
[email protected]
Contact person for scientific queries
Name 140700 0
Chu Luan Nguyen
Address 140700 0
Chris O'Brien Lifehouse, 119-143 Missenden Rd, Camperdown NSW 2050
Country 140700 0
Australia
Phone 140700 0
+61 2 8514 0000
Fax 140700 0
Email 140700 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.