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Minimally Invasive Groin Dissection for Melanoma (SAFE-MILND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01500304
Recruitment Status : Completed
First Posted : December 28, 2011
Last Update Posted : March 23, 2018
Information provided by (Responsible Party):
James W. Jakub, Mayo Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melanoma Procedure: Minimally invasive inguinal lymph node dissection Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Safety of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma
Study Start Date : June 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Minimally invasive surgery
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
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
Other Name: SAFE MILND

Primary Outcome Measures :
  1. Proficiency score per surgery [ Time Frame: Approximately 90 days following surgical procedure ]
    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.

Secondary Outcome Measures :
  1. Morbidity and percentage of patients converted to open surgical procedure [ Time Frame: Approximately 90 days following 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01500304

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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
United States, California
John Wayne Cancer Institute
Santa Monica, California, United States, 90404
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Mayo Clinic
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Principal Investigator: James Jakub, MD Mayo Clinic
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: James W. Jakub, Breast and Melanoma Surgery Section Head, Mayo Clinic Identifier: NCT01500304    
Other Study ID Numbers: 10-007790
First Posted: December 28, 2011    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share data
Keywords provided by James W. Jakub, Mayo Clinic:
Lymph Nodes
Lymph Node Dissection
Minimally invasive
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas