Minimally Invasive Groin Dissection for Melanoma

Study Overview
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Brief Summary
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The purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. It will then be determined if this new operative technique is safe.

Detailed Description
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This study is a multi-center, Phase 1 clinical trial to determine the safety and feasibility of minimally invasive inguinal lymph node dissection for patients with melanoma. Licensed surgeons who have undergone special training, including a course at the Mayo Clinic Rochester in minimally invasive lymph node dissection (MILND) will perform the new procedure at their home institutions. The study will characterize the learning curve of MILND in the clinical setting, and evaluate the safety of the new operative technique. The hypotheses for this study are: 1) minimally invasive groin dissection is a safe procedure. 2) a structured educational training program is a feasible and effective method to train practicing surgeons in this novel procedure and 3) pre-course generic laparoscopic technical skills correlate with minimally invasive superficial groin dissection performance in a clinical setting, including operative oncologic standards and safety metrics.

Official Title
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Feasibility and Safety of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma

Conditions
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Melanoma

Intervention / Treatment
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* Procedure: Minimally invasive inguinal lymph node dissection


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Malignant melanoma present in an inguinal nodal basin requiring superficial inguinal lymph node dissection. Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable. Clinical or radiographic evidence of superficial inguinal lymph node disease or a prior positive single lymph node biopsy of the superficial inguinal basin as an indication for superficial inguinal lymph node disease is acceptable. Patients must be Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and be healthy enough to undergo a general anesthetic (no epidural or spinal anesthetics). Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal greater than 1 year. Patients must be able to return to surgical facility for 30 and/or 90 day (+/- 20 days) for follow-up appointment. Exclusion Criteria: Prior ipsilateral superficial inguinal lymph node dissection Invasion or ulceration of inguinal nodal disease into the overlying skin Prior radiation therapy to the same regional nodal basin.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minimally invasive surgery<br>Minimally invasive inguinal lymph node dissection is a 10-step technique to provide novel inguinal lymph node staging and treatment. | Procedure: Minimally invasive inguinal lymph node dissection<br>* Operative intervention will be a minimally invasive inguinal lymphadenectomy, which is a three trocar technique to the inguinal dissection, that respects the same anatomic boundaries as the conventional open procedure<br>* Other names: SAFE MILND;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proficiency score per surgery | The proficiency score is a function of the lymph nodes pathologically identified, the amount of blood transfused and the operative time. The range is 0 to 3, with higher proficiency in performing the procedure being 3. | Approximately 90 days following surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity and percentage of patients converted to open surgical procedure | Perioperative morbidity will be prospectively collected and reported.Percentage of participants that require conversion from MILND to open procedure (standard of care). Conversion to the open procedure is required if the operation is not progressing, an adequate oncologic procedure cannot be completed or if bleeding is encountered that cannot be safety controlled videoscopically. | Approximately 90 days following surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, Lymph Nodes, Lymph Node Dissection, Minimally invasive