Dataset Information

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.

SUBMITTER: Jakub JW

PROVIDER: S-EPMC4999343 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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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.

Jakub James W JW Terando Alicia M AM Sarnaik Amod A Ariyan Charlotte E CE Faries Mark B MB Zani Sabino S Neuman Heather B HB Wasif Nabil N Farma Jeffrey M JM Averbook Bruce J BJ Bilimoria Karl Y KY Grotz Travis E TE Allred Jacob B Jake JB Suman Vera J VJ Brady Mary Sue MS Tyler Douglas D Wayne Jeffrey D JD Nelson Heidi H

Annals of surgery 20170101 1

<h4>Background</h4>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.<h4>Methods</h4>Twelve melanoma surgeons from 10 institutions without any previous MILND experience, enrolled patients into a prospective study after completing specialized traini ...[more]

PMID: 28009745

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Project description:IntroductionSentinel lymph node dissection is widely used in the staging of endometrial cancer. Variation in surgical techniques potentially impacts diagnostic accuracy and oncologic outcomes, and poses barriers to the comparison of outcomes across institutions or clinical trial sites. Standardization of surgical technique and surgical quality assessment tools are critical to the conduct of clinical trials. By identifying mandatory and prohibited steps of sentinel lymph node (SLN) dissection in endometrial cancer, the purpose of this study was to develop and validate a competency assessment tool for use in surgical quality assurance.MethodsA Delphi methodology was applied, included 35 expert gynecological oncology surgeons from 16 countries. Interviews identified key steps and tasks which were rated mandatory, optional, or prohibited using questionnaires. Using the surgical steps for which consensus was achieved, a competency assessment tool was developed and subjected to assessments of validity and reliability.ResultsSeventy percent consensus agreement standardized the specific mandatory, optional, and prohibited steps of SLN dissection for endometrial cancer and informed the development of a competency assessment tool. Consensus agreement identified 21 mandatory and three prohibited steps to complete a SLN dissection. The competency assessment tool was used to rate surgical quality in three preselected videos, demonstrating clear separation in the rating of the skill level displayed with mean skills summary scores differing significantly between the three videos (F score=89.4; P<0.001). Internal consistency of the items was high (Cronbach α=0.88).ConclusionSpecific mandatory and prohibited steps of SLN dissection in endometrial cancer have been identified and validated based on consensus among a large number of international experts. A competency assessment tool is now available and can be used for surgeon selection in clinical trials and for ongoing, prospective quality assurance in routine clinical care.

Project description:BackgroundLymph nodes dissection in esophagectomy is an essential procedure for radical resection, which can not only provide more accurate staging but may also improve survival, while it is technically challenging and may lead to recurrent laryngeal nerve (RLN) paralysis. Numerous efforts have been directed to achieve the dissection of more LNs around the RLN and to lower the incidence of RLN palsy, including Bascule method and modified Bascule method. On this basis, we modified and applied a novel method which involves the en bloc dissection of lymph nodes dissection along the left RLN in McKeown minimally invasive esophagectomy (MIE).MethodsA total of 244 consecutive cases of lymphadenectomy along the left RLN during McKeown MIE at our institution between January 2018 and August 2021 were retrospectively analyzed. The cases were divided into two groups based on the methods of lymphadenectomy along the left RLN: 77 cases received the conventional method (CM group) and 167 cases received the novel method (NM group). The surgical outcomes, especially the impact of surgical proficiency on the outcomes of lymphadenectomy along the left RLN, were assessed and compared between the two groups.ResultsDemographic data of the two cohorts were similar. The number of harvested lymph nodes (LNs) (total/abdomen/left RLN) in the NM group was markedly higher than that in the CM group (32 vs. 27, P=0.006; 11 vs. 9, P=0.038; 3 vs. 2, P=0.044). However, the number of harvested LNs from the chest or right RLN was not significantly different in the two groups. The hoarseness rate was 1.8% in the NM group, which was slightly but not notably lower than that of the CM group (1.8% vs. 2.6%, P=0.681). The incidence of LN metastasis along the left RLN was 13.9%, 15.6%, and 13.2% in the whole cohort, CM group, and NM group, respectively.ConclusionsOur novel method not only increased the number of LN dissections along left RLN but also slightly reduced the incidence of hoarseness. Therefore, this novel method of lymphadenectomy along the left RLN during McKeown MIE is safe and reliable.

Dataset Information

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

Publications

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

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