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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive surgery | Experimental | Minimally invasive inguinal lymph node dissection is a 10-step technique to provide novel inguinal lymph node staging and treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive inguinal lymph node dissection | Procedure | Operative intervention will be a minimally invasive inguinal lymphadenectomy, which is a three trocar technique to the inguinal dissection, that respects the same anatomic boundaries as the conventional open procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity and percentage of patients converted to open surgical procedure | Perioperative morbidity will be prospectively collected and reported.Percentage of participants that require conversion from MILND to open procedure (standard of care). Conversion to the open procedure is required if the operation is not progressing, an adequate oncologic procedure cannot be completed or if bleeding is encountered that cannot be safety controlled videoscopically. |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Jakub, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States | ||
| John Wayne Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17336247 | Background | Jakub JW, Reintgen DS, Shivers S, Pendas S. Regional node dissection for melanoma: techniques and indication. Surg Oncol Clin N Am. 2007 Jan;16(1):247-61. doi: 10.1016/j.soc.2006.10.012. | |
| 22875645 | Background | Abbott AM, Grotz TE, Rueth NM, Hernandez Irizarry RC, Tuttle TM, Jakub JW. Minimally invasive inguinal lymph node dissection (MILND) for melanoma: experience from two academic centers. Ann Surg Oncol. 2013 Jan;20(1):340-5. doi: 10.1245/s10434-012-2545-6. Epub 2012 Aug 9. |
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no plan to share data
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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|
|
| Approximately 90 days following surgical procedure |
| Santa Monica |
| California |
| 90404 |
| United States |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| 28009745 | Derived | Jakub JW, Terando AM, Sarnaik A, Ariyan CE, Faries MB, Zani S Jr, Neuman HB, Wasif N, Farma JM, Averbook BJ, Bilimoria KY, Grotz TE, Allred JB, Suman VJ, Brady MS, Tyler D, Wayne JD, Nelson H. Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND): Report of a Prospective Multi-institutional Trial. Ann Surg. 2017 Jan;265(1):192-196. doi: 10.1097/SLA.0000000000001670. |
| 26711792 | Derived | Jakub JW, Terando AM, Sarnaik A, Ariyan CE, Faries MB, Zani S Jr, Neuman HB, Wasif N, Farma JM, Averbook BJ, Bilimoria KY, Allred JB, Suman VJ, Grotz TE, Zendejas B, Wayne JD, Tyler DS. Training High-Volume Melanoma Surgeons to Perform a Novel Minimally Invasive Inguinal Lymphadenectomy: Report of a Prospective Multi-Institutional Trial. J Am Coll Surg. 2016 Mar;222(3):253-60. doi: 10.1016/j.jamcollsurg.2015.11.010. Epub 2015 Nov 25. |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |