Minimally Invasive Groin Dissection for Melanoma (SAFE-MILND)

Mayo Clinic

Status: Completed

Conditions: Melanoma

Treatments: Procedure: Minimally invasive inguinal lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT01500304

10-007790

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

Minimally invasive surgery

Experimental group

Description:

Minimally invasive inguinal lymph node dissection is a 10-step technique to provide novel inguinal lymph node staging and treatment.

Treatment:

Procedure: Minimally invasive inguinal lymph node dissection