Feasibility and Safety of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma

Location:

Phoenix/Scottsdale, Ariz.

Trial status:

Open for Enrollment

Why is this study being done?

This study is a multi-center, Phase 1 clinical trial to determine the safety and feasibility of minimally invasive inguinal lymph node dissection for patients with melanoma. Licensed surgeons who have undergone special training, including a course at the Mayo Clinic Rochester in minimally invasive lymph node dissection (MILND) will perform the new procedure at their home institutions. The study will characterize the learning curve of MILND in the clinical setting, and evaluate the safety of the new operative technique. The hypotheses for this study are: 1) minimally invasive groin dissection is a safe procedure. 2) a structured educational training program is a feasible and effective method to train practicing surgeons in this novel procedure and 3) pre-course generic laparoscopic technical skills correlate with minimally invasive superficial groin dissection performance in a clinical setting, including operative oncologic standards and safety metrics.

Who is eligible to participate?

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.

Last updated:

4/8/2014

NCT ID:

NCT01500304

IRB Number:

10-007790