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

Publication ,  Journal Article
Jakub, JW; Terando, AM; Sarnaik, A; Ariyan, CE; Faries, MB; Zani, S; Neuman, HB; Wasif, N; Farma, JM; Averbook, BJ; Bilimoria, KY; Grotz, TE ...
Published in: Ann Surg
January 2017

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.

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Published In

Ann Surg

DOI

EISSN

1528-1140

Publication Date

January 2017

Volume

265

Issue

1

Start / End Page

192 / 196

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Surgery
  • Skin Neoplasms
  • Prospective Studies
  • Patient Safety
  • Minimally Invasive Surgical Procedures
  • Middle Aged
  • Melanoma
  • Male
 

Citation

APA
Chicago
ICMJE
MLA
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Jakub, J. W., Terando, A. M., Sarnaik, A., Ariyan, C. E., Faries, M. B., Zani, S., … Nelson, H. (2017). 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, 265(1), 192–196. https://doi.org/10.1097/SLA.0000000000001670
Jakub, James W., Alicia M. Terando, Amod Sarnaik, Charlotte E. Ariyan, Mark B. Faries, Sabino Zani, Heather B. Neuman, et al. “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 265, no. 1 (January 2017): 192–96. https://doi.org/10.1097/SLA.0000000000001670.
Jakub, James W., et al. “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, vol. 265, no. 1, Jan. 2017, pp. 192–96. Pubmed, doi:10.1097/SLA.0000000000001670.
Jakub JW, Terando AM, Sarnaik A, Ariyan CE, Faries MB, Zani S, Neuman HB, Wasif N, Farma JM, Averbook BJ, Bilimoria KY, Grotz TE, Allred JBJ, 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.

Published In

Ann Surg

DOI

EISSN

1528-1140

Publication Date

January 2017

Volume

265

Issue

1

Start / End Page

192 / 196

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Surgery
  • Skin Neoplasms
  • Prospective Studies
  • Patient Safety
  • Minimally Invasive Surgical Procedures
  • Middle Aged
  • Melanoma
  • Male