Minimally Invasive Groin Dissection for Melanoma
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
Site IRB
- Rochester, Minnesota: 10-007790
- Jacksonville, Florida: 10-007790
- Scottsdale/Phoenix, Arizona: 10-007790
NCT ID: NCT01500304
Sponsor Protocol Number: 10-007790
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
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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