LYMPHA Procedure for the Prevention of Lymphedema After Axillary Lymphadenectomy

Part of paid clinical trials in San Francisco, California.

Sponsor
Stanford University
Study ID
NCT05366699
Status
Recruiting
Apply to this trial

Conditions

  • Lymphedema
  • Lymphedema, Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) — PROCEDURE
    lymphatic reconstruction where the cut lymphatic vessels are reconstructed by anastamosing to the veins
  • Axillary lymphadenetomy alone — PROCEDURE
    oncologic axillary lymphadenectomy
  • axillary lymphadenectomy with soft tissue reinforcement — PROCEDURE
    axillary lymphadenectomy with soft tissue reinforcement(STR)

Study Details

Lymphedema is a chronic, progressive, and debilitating condition that occurs with disruption or obstruction of the lymphatic system, which commonly occurs a result of breast cancer therapy. The purpose of this study is to determine if the use of a low risk lymphatic reconstruction procedure at the time of axillary lymph node dissection will reduce the risk of developing lymphedema. Additionally, to determine if this procedure improves objective outcomes of lymphedema and patient quality of life

Key Dates

Start date
Sep 10, 2021
Status verified
Dec 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Other: Group A
    Group A will under axillary lymphadenectomy alone
  • Active Comparator: Group B
    Group B will undergo axillary lymphadenectomy with soft tissue reinforcement(STR)
  • Experimental: Group C
    Group B will undergo axillary lymphadenectomy with immediate lymphatic reconstruction (LYMPHA) using reverse mapping using the SPY System.

Primary Outcome Measure

Lymphatic flow pattern of whole limb [ Time Frame: 2 yr ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstituteSan FranciscoCalifornia94305
Dung Nguyen, PharmD
[email protected]
650-498-6004
Irene Wapnir, MD (SUB_INVESTIGATOR)
Mardi Karin, MD (SUB_INVESTIGATOR)
Frederick Dirbas, MD (SUB_INVESTIGATOR)
Jacqueline Tsai, MD (SUB_INVESTIGATOR)
Kimberly Stone, MD (SUB_INVESTIGATOR)
Dung Nguyen, PharmD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
Stanford Cancer Institute· San Francisco, CA

Related Studies