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Minimally Invasive Groin Dissection for Melanoma

Overview

About this study

The purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. It will then be determined if this new operative technique is safe.

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion criteria:

  • Malignant melanoma present in an inguinal nodal basin requiring superficial inguinal lymph node dissection.
  • Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable.
  • Clinical or radiographic evidence of superficial inguinal lymph node disease or a prior positive single lymph node biopsy of the superficial inguinal basin as an indication for superficial inguinal lymph node disease is acceptable.
  • Patients must be Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and be healthy enough to undergo a general anesthetic (no epidural or spinal anesthetics).
  • Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal greater than 1 year.
  • Patients must be able to return to surgical facility for 30 and/or 90 day (+/- 20 days) for follow-up appointment.

Exclusion Criteria:

  • Prior ipsilateral superficial inguinal lymph node dissection
  • Invasion or ulceration of inguinal nodal disease into the overlying skin
  • Prior radiation therapy to the same regional nodal basin.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

James Jakub, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

Jacksonville, Fla.

Mayo Clinic principal investigator

James Jakub, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

James Jakub, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

More information

Publications

  • Regional lymph nodes are the most frequent site of spread of metastatic melanoma. Operative intervention remains the only potential for cure, but the reported morbidity rate associated with inguinal lymphadenectomy is approximately 50%. Minimally invasive lymph node dissection (MILND) is an alternative approach to traditional, open inguinal lymph node dissection (OILND). The aim of this study is to evaluate our early experience with MILND and compare this with our OILND experience. Read More on PubMed
  • Because virtually all microscopic nodal disease left untreated in melanoma patients will progress to clinically apparent macroscopic nodal disease, there is worse prognosis with macroscopic nodal disease, and ineffective systemic treatment currently exists, one must be cautious in favoring an observation approach to the regional basin in patients with a positive sentinel lymph node (SLN) in the hopes of avoiding the potential morbidity of a therapeutic node dissection. In the few patients with untreated microscopic nodal disease, the prognosis will be significantly worsened. Until further data are available, melanoma patients with a positive SLN by H&E analysis should proceed to a complete lymph node dissection. Read More on PubMed

More about research at Mayo Clinic

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CLS-20151674

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