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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proficiency score per surgery

Outcome Description:

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.

Outcome Time Frame:

Approximately 90 days following surgical procedure

Safety Issue:

No

Principal Investigator

James Jakub, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

10-007790

NCT ID:

NCT01500304

Start Date:

June 2012

Completion Date:

June 2013

Related Keywords:

  • Melanoma
  • Melanoma
  • Lymph Nodes
  • Lymph Node Dissection
  • Minimally invasive
  • Melanoma

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Northwestern Memorial HospitalChicago, Illinois  60611
John Wayne Cancer InstituteSanta Monica, California  90404
MetroHealth Medical CenterCleveland, Ohio  44109
Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404
Mayo Clinic in FloridaJacksonville, Florida  32224
Duke University Medical CenterDurham, North Carolina  27710
University of WisconsinMadison,, Wisconsin  53792-5666
The Ohio State University Medical CenterColumbus, Ohio  43210