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NCT06650592 | NOT YET RECRUITING | Lymphatic Reconstruction


Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA
Sponsor:

University of Chicago

Brief Summary:

Immediate lymphatic reconstruction (ILR) is a novel surgical approach performed at the time of initial lymph node dissection with the goal of preventing lymphedema. It involves the identification of lymphatic channels that are transected after lymph node dissection and microsurgical anastomosis of one or more lymphatic channel with a local recipient vein to re-direct upper extremity lymphatic drainage. Although ILR carries significant promise in prevention of lymphedema, there is a lack of high-level evidence supporting its efficacy because it is a novel surgical technique that is only offered at a few centers and not routinely covered by insurance carriers yet. The University of Chicago Comprehensive Cancer Center (UCCCC) is one of the busiest microsurgery centers performing this procedure, and, as a Lymphedema Center of Excellence, is in a unique position to investigate the efficacy of ILR in preventing lymphedema. In addition, the University has access to a world class microbiome research facility and colleagues. There is no information on the skin microbiome of the axilla in patients undergoing treatment for breast cancer or those at risk for developing lymphedema. Further exploratory studies such as this in a diverse patient population may lead to practice changing research in our approach to lymphedema management and prevention. The purpose of this study is to determine the role of immediate lymphatic reconstruction and obtain objective data to correlate the existing, self-reported rates of lymphedema at the University of Chicago.

Condition or disease

Lymphatic Reconstruction

Intervention/treatment

All patients who were candidates for immediate lymphatic reconstruction (ILR)

Study Type : OBSERVATIONAL
Estimated Enrollment : 90 participants
Official Title : Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2029-10
Estimated Study Completion Date : 2029-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * All patients who were candidates for Immediate Lymphatic Reconstruction (ILR)
Exclusion Criteria
  • * None

Objective Assessment of Outcomes Following Immediate Lymphatic Reconstruction / LYMPHA

Location Details

NCT06650592


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Locations


Not yet recruiting

United States, Illinois

The University o Chicago

Chicago, Illinois, United States, 60637

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