Minimally Invasive Groin Dissection for Melanoma



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:June 2012
End Date:December 2015

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

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.

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.

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.
We found this trial at
11
sites
251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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2200 Santa Monica Blvd
Santa Monica, California 90404
(310) 582-7438
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Santa Monica, CA
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Cleveland, OH
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Columbus, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
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Jacksonville, FL
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Madison, WI
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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Scottsdale, AZ
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