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 Jean Suman, Mary Sue Brady, Douglas Tyler, Jeffrey D. Wayne, Heidi Nelson

Research output: Contribution to journalArticle

10 Citations (Scopus)

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)
JournalAnnals of Surgery
DOIs
StateAccepted/In press - Feb 25 2016

Fingerprint

Groin
Lymph Node Excision
Melanoma
Safety
Lymph Nodes
Benchmarking
Phase II Clinical Trials
Clinical Trials, Phase I
National Cancer Institute (U.S.)
Terminology
Prospective Studies
Guidelines
Morbidity
Education

ASJC Scopus subject areas

  • Surgery

Cite this

Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND) : Report of a Prospective Multi-institutional Trial. / Jakub, James W; Terando, Alicia M.; Sarnaik, Amod; Ariyan, Charlotte E.; Faries, Mark B.; Zani, Sabino; Neuman, Heather B.; Wasif, Nabil; Farma, Jeffrey M.; Averbook, Bruce J.; Bilimoria, Karl Y.; Grotz, Travis E.; Allred, Jacob B (Jake); Suman, Vera Jean; Brady, Mary Sue; Tyler, Douglas; Wayne, Jeffrey D.; Nelson, Heidi.

In: Annals of Surgery, 25.02.2016.

Research output: Contribution to journalArticle

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 2016, 'Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND): Report of a Prospective Multi-institutional Trial', Annals of Surgery. https://doi.org/10.1097/SLA.0000000000001670
Jakub, James W ; Terando, Alicia M. ; Sarnaik, Amod ; Ariyan, Charlotte E. ; Faries, Mark B. ; Zani, Sabino ; Neuman, Heather B. ; Wasif, Nabil ; Farma, Jeffrey M. ; Averbook, Bruce J. ; Bilimoria, Karl Y. ; Grotz, Travis E. ; Allred, Jacob B (Jake) ; Suman, Vera Jean ; Brady, Mary Sue ; Tyler, Douglas ; Wayne, Jeffrey D. ; Nelson, Heidi. / Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND) : Report of a Prospective Multi-institutional Trial. In: Annals of Surgery. 2016.
@article{d834e41f57b944aab1096ac9afca450b,
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 = "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.",
author = "Jakub, {James W} and Terando, {Alicia M.} and Amod Sarnaik and Ariyan, {Charlotte E.} and Faries, {Mark B.} and Sabino Zani and Neuman, {Heather B.} and Nabil Wasif and Farma, {Jeffrey M.} and Averbook, {Bruce J.} and Bilimoria, {Karl Y.} and Grotz, {Travis E.} and Allred, {Jacob B (Jake)} and Suman, {Vera Jean} and Brady, {Mary Sue} and Douglas Tyler and Wayne, {Jeffrey D.} and Heidi Nelson",
year = "2016",
month = "2",
day = "25",
doi = "10.1097/SLA.0000000000001670",
language = "English (US)",
journal = "Annals of Surgery",
issn = "0003-4932",
publisher = "Lippincott Williams and Wilkins",

}

TY - JOUR

T1 - Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND)

T2 - Report of a Prospective Multi-institutional Trial

AU - Jakub, James W

AU - Terando, Alicia M.

AU - Sarnaik, Amod

AU - Ariyan, Charlotte E.

AU - Faries, Mark B.

AU - Zani, Sabino

AU - Neuman, Heather B.

AU - Wasif, Nabil

AU - Farma, Jeffrey M.

AU - Averbook, Bruce J.

AU - Bilimoria, Karl Y.

AU - Grotz, Travis E.

AU - Allred, Jacob B (Jake)

AU - Suman, Vera Jean

AU - Brady, Mary Sue

AU - Tyler, Douglas

AU - Wayne, Jeffrey D.

AU - Nelson, Heidi

PY - 2016/2/25

Y1 - 2016/2/25

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=84959246803&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84959246803&partnerID=8YFLogxK

U2 - 10.1097/SLA.0000000000001670

DO - 10.1097/SLA.0000000000001670

M3 - Article

C2 - 28009745

AN - SCOPUS:84959246803

JO - Annals of Surgery

JF - Annals of Surgery

SN - 0003-4932

ER -