Feasibility and Safety of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Proficiency score per surgery
The proficiency score is a function of the lymph nodes pathologically identified, the amount of blood transfused and the operative time. The range is 0 to 3, with higher proficiency in performing the procedure being 3.
Approximately 90 days following surgical procedure
No
James Jakub, MD
Principal Investigator
Mayo Clinic
United States: Institutional Review Board
10-007790
NCT01500304
June 2012
June 2013
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Northwestern Memorial Hospital | Chicago, Illinois 60611 |
John Wayne Cancer Institute | Santa Monica, California 90404 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Duke University Medical Center | Durham, North Carolina 27710 |
University of Wisconsin | Madison,, Wisconsin 53792-5666 |
The Ohio State University Medical Center | Columbus, Ohio 43210 |