title: Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND): Report of a Prospective Multi-institutional Trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: *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.
authors.forename: James W
authors.initials: JW
authors.lastname: Jakub
authors.forename: Alicia M
authors.initials: AM
authors.lastname: Terando
authors.forename: Amod
authors.initials: A
authors.lastname: Sarnaik
authors.forename: Charlotte E
authors.initials: CE
authors.lastname: Ariyan
authors.forename: Mark B
authors.initials: MB
authors.lastname: Faries
authors.forename: Sabino
authors.initials: S
authors.lastname: Zani
authors.forename: Heather B
authors.initials: HB
authors.lastname: Neuman
authors.forename: Nabil
authors.initials: N
authors.lastname: Wasif
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Farma
authors.forename: Bruce J
authors.initials: BJ
authors.lastname: Averbook
authors.forename: Karl Y
authors.initials: KY
authors.lastname: Bilimoria
authors.forename: Travis E
authors.initials: TE
authors.lastname: Grotz
authors.forename: Jacob B Jake
authors.initials: JB
authors.lastname: Allred
authors.forename: Vera J
authors.initials: VJ
authors.lastname: Suman
authors.forename: Mary Sue
authors.initials: MS
authors.lastname: Brady
authors.forename: Douglas
authors.initials: D
authors.lastname: Tyler
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Wayne
authors.forename: Heidi
authors.initials: H
authors.lastname: Nelson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006119:Groin; D006801:Humans; D008197:Lymph Node Excision / Q000379:methods*; D008207:Lymphatic Metastasis; D008297:Male; D008545:Melanoma / Q000473:pathology / Q000601:surgery*; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures; D061214:Patient Safety; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000473:pathology / Q000601:surgery*; D016896:Treatment Outcome; D055815:Young Adult