A Study to See if Immediate Lymphatic Reconstruction Decreases the Risk of Lymphedema after Axillary Lymph Node Removal during Breast Cancer Surgery

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Full Title

A Randomized Control Trial: Does Immediate Lymphatic Reconstruction Decrease the Incidence of Lymphedema After Axillary Lymph Node Dissection?

Purpose

Breast cancer can spread to lymph nodes under the arm (“axillary nodes”). Surgeons remove and examine the first lymph nodes to which cancer cells might spread (sentinel nodes) to determine the extent of cancer spread and to guide treatment. Sometimes all the lymph nodes under the arm need to be removed (a procedure called “axillary lymph node dissection”). Removing many lymph nodes can sometimes cause a problem called lymphedema, where fluid collects in the affected arm, which can be uncomfortable.

In this study, researchers want to see if reconstructing lymphatic drainage of the arm immediately after axillary lymph node dissection can reduce the chance of lymphedema developing and improve patients’ quality of life. Patients will be randomly assigned to undergo standard axillary lymph node dissection alone or to have lymphatic reconstruction immediately after axillary node dissection. This decision will be made in the operating room.

Who Can Join

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be women scheduled to have axillary lymph node dissection (or sentinel lymph node biopsy with a high chance of needing an axillary lymph node dissection) on one side during breast cancer surgery.
  • Patients must have at least one lymphatic channel and at least one vein that could be used to perform lymphatic reconstruction.
  • This study is for women ages 18 to 75.

For more information and to inquire about eligibility for this study, please contact Dr. Michelle Coriddi at 212-639-3868.

Protocol

20-021

Phase

III

Investigator

ClinicalTrials.gov ID

NCT04241341