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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
PMID: 28009745    PMCID: PMC4999343    URL: https://www.ncbi.nlm.nih.gov/pubmed/28009745
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BACKGROUND: Minimally invasive inguinal lymph node dissection (MILND) is a novel approach to inguinal lymphadenectomy. SAFE-MILND (NCT01500304) is a multicenter, phase I/II clinical trial evaluating the safety and feasibility of MILND for patients with melanoma in a group of surgeons newly adopting the procedure. METHODS: Twelve melanoma surgeons from 10 institutions without any previous MILND experience, enrolled patients into a prospective study after completing specialized training including didactic lectures, participating in a hands-on cadaveric laboratory, and being provided an instructional DVD of the procedure. Complications and adverse postoperative events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.0. RESULTS: Eighty-seven patients underwent a MILND. Seventy-seven cases (88.5%) were completed via a minimally invasive approach. The median total inguinal lymph nodes pathologically examined (SLN + MILND) was 12.0 (interquartile range 8.0, 14.0). Overall, 71% of patients suffered an adverse event (AE); the majority of these were grades 1 and 2, with 26% of patients experiencing a grade 3 AE. No grade 4 or 5 AEs were observed. CONCLUSIONS: After a structured training program, high-volume melanoma surgeons adopted a novel surgical technique with a lymph node retrieval rate that met or exceeded current oncologic guidelines and published benchmarks, and a favorable morbidity profile.
Jakub, James W Terando, Alicia M Sarnaik, Amod Ariyan, Charlotte E Faries, Mark B Zani, Sabino Jr Neuman, Heather B Wasif, Nabil Farma, Jeffrey M Averbook, Bruce J Bilimoria, Karl Y Grotz, Travis E Allred, Jacob B Jake Suman, Vera J Brady, Mary Sue Tyler, Douglas Wayne, Jeffrey D Nelson, Heidi eng K23 CA178083/CA/NCI NIH HHS/ 2016/12/24 06:00 Ann Surg. 2017 Jan;265(1):192-196. doi: 10.1097/SLA.0000000000001670.