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

    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 J.; 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 J. ; 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.
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    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.",
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    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 J.

    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.

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