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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-11065 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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slow accrual; diminished funding
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The researchers are trying to answer if axillary reverse mapping (ARM) with lympho-venous bypass (LVB) in patients undergoing an axillary lymph node dissection reduces the rate and severity of post-operative lymphedema of the arm.
All subjects will undergo an axillary lymph node dissection (ALND). Cluster randomization will determine which of these subjects will have the ARM with LVB and which subjects will have the ALND without this technique. As a baseline, all subjects will have the circumference of their arms measured and complete a questionnaire about lymphedema. Performing the measurements and answering a questionnaire will be repeated at 6, 12, 24, and 36 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALND with ARM +/- LVB | Experimental | Axillary Lymph Node Dissection (ALND) using Axillary Reverse Mapping (ARM) with Lympho-venous bypass (LVB) will be performed. |
|
| ALND without ARM +/- LVB | Active Comparator | Axillary Lymph Node Dissection (ALND) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALND with ARM +/- LVB | Procedure | Subjects will undergo removal of the lymph nodes in the underarm or "axilla" area. This is referred to as an axillary lymph node dissection (ALND). The procedure for identifying the drainage of the arm lymphatics during an axillary dissection has been coined axillary reverse mapping (ARM). Lympho-venous bypass (LVB) is a technique incorporated along with the ARM procedure that allows preservation of the lymphatics draining the arm while removing the standard lymph nodes and not compromising the extent of the axillary dissection. |
| Measure | Description | Time Frame |
|---|---|---|
| Less than 5% limb volume increase in the study extremity compared to baseline and the control extremity | Bilateral Limb volume measurements | 36 months following surgery |
| Less frequently reported symptoms of lymphedema in the study extremity compared to baseline and the control extremity | Validated patient reported surveys | 36 months following surgery |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| James W Jakub, MD | Mayo Clinic | Principal Investigator |
| Mara A. Piltin, DO | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States | ||
| Mayo Clinic in Rochester |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| ALND | Procedure | Prospective and retrospective subjects undergoing an ALND. |
|
| Rochester |
| Minnesota |
| 55905 |
| United States |
| D001941 |
| Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |