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, Travis E. Grotz, Jacob B Jake Allred, Vera J. Suman, Mary Sue Brady, Douglas Tyler, Jeffrey D. Wayne, Heidi Nelson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

18 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)192-196
Number of pages5
JournalAnnals of surgery
Volume265
Issue number1
DOIs
StatePublished - 2017

Keywords

  • Benchmarks
  • Complications
  • Endoscopic
  • Groin dissection
  • Inguinal
  • Laparoscopic
  • Lymph node count
  • Melanoma
  • Minimally invasive
  • Seroma
  • Videoscopic
  • Wound infection

ASJC Scopus subject areas

  • Surgery

Fingerprint Dive into the research topics of 'Safety and feasibility of minimally invasive inguinal lymph node dissection in patients with melanoma (SAFE-MILND): Report of a prospective multi-institutional trial'. Together they form a unique fingerprint.

Cite this