Minimally Invasive Groin Dissection for Melanoma

NCT01500304 | Completed DMC

• 1 other identifier: 10-007790
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 11

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.

Conditions

Melanoma

Keywords

Melanoma; Lymph Nodes; Lymph Node Dissection; Minimally invasive

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Morbidity and percentage of patients converted to open surgical procedure

  Approximately 90 days following surgical procedure

Study Arms (1)

Minimally invasive surgery

EXPERIMENTAL

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

Interventions

Minimally invasive inguinal lymph node dissection PROCEDURE

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

Also known as: SAFE MILND

Minimally invasive surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (11)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

John Wayne Cancer Institute

Santa Monica, California, 90404, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (4)

• 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. doi: 10.1016/j.soc.2006.10.012.

  PMID: 17336247 BACKGROUND

• 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.

  PMID: 22875645 BACKGROUND

• Jakub JW, Terando AM, Sarnaik A, Ariyan CE, Faries MB, Zani S Jr, Neuman HB, Wasif N, Farma JM, Averbook BJ, Bilimoria KY, Grotz TE, Allred JB, Suman VJ, Brady MS, Tyler D, Wayne JD, Nelson H. Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND): Report of a Prospective Multi-institutional Trial. Ann Surg. 2017 Jan;265(1):192-196. doi: 10.1097/SLA.0000000000001670.

  PMID: 28009745 DERIVED

• Jakub JW, Terando AM, Sarnaik A, Ariyan CE, Faries MB, Zani S Jr, Neuman HB, Wasif N, Farma JM, Averbook BJ, Bilimoria KY, Allred JB, Suman VJ, Grotz TE, Zendejas B, Wayne JD, Tyler DS. Training High-Volume Melanoma Surgeons to Perform a Novel Minimally Invasive Inguinal Lymphadenectomy: Report of a Prospective Multi-Institutional Trial. J Am Coll Surg. 2016 Mar;222(3):253-60. doi: 10.1016/j.jamcollsurg.2015.11.010. Epub 2015 Nov 25.

  PMID: 26711792 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• James Jakub, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Breast and Melanoma Surgery Section Head

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: December 28, 2011
• Study Start: June 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)