Preventing Lymphedema in Axillary Lymph Node Dissection

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 16-010491
    • Rochester, Minnesota: 16-010491
    NCT ID: NCT03428581
    Sponsor Protocol Number: 16-010491

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Patients scheduled to undergo an axillary lymph node dissection
  • Patients who in the surgeon's judgement are at high risk to convert to an axillary lymph node dissection based intraoperative findings
  • English speaking

Exclusion Criteria

  • Prior ipsilateral axillary lymph node dissection
  • Prior ipsilateral axillary radiation
  • Patients undergoing sentinel lymph node biopsy only or at low risk of converting to an axillary lymph node dissection in the surgeon's judgement
  • Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
  • Pregnant patients cannot participate in the substudy

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

James Jakub, M.D.

Contact us for the latest status

Contact information:

Sheri Ramaker R.N.

(507)538-6984

ramaker.sheri@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

James Jakub, M.D.

Contact us for the latest status

Contact information:

Sheri Ramaker R.N.

(507)538-6984

ramaker.sheri@mayo.edu

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CLS-20359609

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