Preventing Lymphedema in Patients Undergoing Axillary Lymph Node Dissection with Axillary Reverse Mapping and Lympho-venous Bypass

Overview

  • Study type

    Observational
  • 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
    Sponsor Protocol Number: 16-010491

About this study

Primary AIM

  • To determine if axillary reverse mapping with lympho-venous bypass decreases the incidence and severity of lymphedema in patients undergoing axillary lymph node dissection.

Secondary AIM

  • To determine how often the lymph node draining the arm is involved with metastatic cancer.

  • To determine short and long term lymphatic drainage patterns in patients undergoing axillary reverse lymphatic mapping with lympho-venous bypass compared to patients who underwent a standard axillary lymph node dissection.

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 must be at least 18 years of age
  • 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 disseciton in the surgeon’s judgement
  • Previous treatment for lymphedema of either arm or prescribed prophylactic treatment for lymphedema.
  • Pregnant patients

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