• Annals of surgery · Jan 2017

    Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND): Report of a Prospective Multi-institutional Trial.

    • James W Jakub, Alicia M Terando, Amod Sarnaik, Charlotte E Ariyan, Mark B Faries, Sabino Zani, Heather B Neuman, Nabil Wasif, Jeffrey M Farma, Bruce J Averbook, Karl Y Bilimoria, and Travis E Grotz.
    • *Department of Surgery, Mayo Clinic, Rochester, MN †Department of Surgery, Ohio State University Medical Center, Columbus, OH ‡Department of Surgery, H. Lee Moffitt Cancer Center, Tampa, FL §Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY ¶Department of Surgical Oncology, John Wayne Cancer Institute, Santa Monica, CA ||Department of Surgery, Duke University School of Medicine, Durham, NC **Division of General Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI ††Department of Surgery, Mayo Clinic, Phoenix, AZ ‡‡Department of Surgery, Fox Chase Cancer Center, Philadelphia, PA §§Department of Surgery, MetroHealth Medical Center, Cleveland, OH ¶¶Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL ||||Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN ***Department of Surgery, University of Texas Medical Branch, Galveston, TX.
    • Ann. Surg. 2017 Jan 1; 265 (1): 192-196.

    BackgroundMinimally 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.MethodsTwelve 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.ResultsEighty-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.ConclusionsAfter 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.

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