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Minimally Invasive Groin Dissection for Melanoma (SAFE-MILND)

This study is currently recruiting participants.
Verified March 2013 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
James W. Jakub, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01500304
First received: December 22, 2011
Last updated: March 28, 2013
Last verified: March 2013
History of Changes

December 22, 2011
March 28, 2013
June 2012
June 2013   (final data collection date for primary outcome measure)
Proficiency score per surgery [ Time Frame: Approximately 90 days following surgical procedure ] [ Designated as safety issue: No ]
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.
Proficiency score per surgery [ Time Frame: At completion of surgery ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01500304 on ClinicalTrials.gov Archive Site
Morbidity and percentage of patients converted to open surgical procedure [ Time Frame: Approximately 90 days following surgical procedure ] [ Designated as safety issue: No ]
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.
Morbidity and percentage of patients converted to open surgical procedure [ Time Frame: After completion of surgery ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Minimally Invasive Groin Dissection for Melanoma
Feasibility and Safety of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma

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.

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.
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
Procedure: Minimally invasive inguinal lymph node dissection
Experimental: Minimally invasive surgery
Minimally invasive inguinal lymph node dissection is a 10-step technique to provide novel inguinal lymph node staging and treatment.
Intervention: Procedure: Minimally invasive inguinal lymph node dissection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: James Jakub, MD 507-284-0362 jakub.james@mayo.edu
United States
 
NCT01500304
10-007790
Yes
James W. Jakub, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: James Jakub, MD Mayo Clinic
Mayo Clinic
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP