Minimally Invasive Groin Dissection for Melanoma

Melanoma Clinical Trial

— SAFE-MILND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500304
• Other study ID #: 10-007790
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: March 21, 2018
• Start date: June 2012
• Est. completion date: December 2015

Study information

• Verified date: March 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	The Ohio State University Medical Center	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	University of Wisconsin	Madison	Wisconsin
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	John Wayne Cancer Institute	Santa Monica	California
United States	Mayo Clinic in Arizona	Scottsdale	Arizona
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

Abbott AM, Grotz TE, Rueth NM, Hernandez Irizarry RC, Tuttle TM, Jakub JW. Minimally invasive inguinal lymph node dissection (MILND) for melanoma: experience from two academic centers. Ann Surg Oncol. 2013 Jan;20(1):340-5. doi: 10.1245/s10434-012-2545-6. Epub 2012 Aug 9. — View Citation

Jakub JW, Reintgen DS, Shivers S, Pendas S. Regional node dissection for melanoma: techniques and indication. Surg Oncol Clin N Am. 2007 Jan;16(1):247-61. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Mayo Clinic Clinical Trials