A Non-Randomized Study to Evaluate Leg Lymphatic Drainage Associated With Surgical Intervention for Vulvar Cancer

Vulvar Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01321697
• Other study ID #: 110583
• Status: Terminated
• Phase: N/A
• First received: March 22, 2011
• Last updated: August 23, 2013
• Start date: March 2011
• Est. completion date: June 2012

Study information

• Verified date: August 2013
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This will be a non-blinded, non-randomized study to further our knowledge of and experience with lymph node surgery. The investigators are interested in documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy (SLNB) with inguinal-femoral lymph node dissection (IFLND). The study will be open at the Winthrop P. Rockefeller Cancer Institute at The University of Arkansas for Medical Sciences (UAMS). Dr. Pamela Stone, Dr.Alexander Burnett, and Dr. Juan Roman will be responsible for accruing subjects to this study. It will be open to all patients presenting to the Winthrop P. Rockefeller Cancer Institute with vulvar cancer requiring lymph node evaluation for the ipsilateral and/or contralateral groin who have not had prior groin surgery or radiation to the groins. Patients must meet inclusion and exclusion criteria to be enrolled.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients 18-100 years of age.

• All races and ethnicities.

• Being seen in the Winthrop P. Rockefeller Cancer Institute for vulvar cancer requiring lymph node evaluation for the ipsilateral or contralateral groin.

• Willing participation following informed consent process.

Exclusion Criteria:

• Has not had prior groin surgery or radiation to the groins.

• Any condition the PI or study physician determines that will put the subject at risk during the procedure.

• Allergy to blue dye used in lymphatic identification.

• Pregnant or breast feeding.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Procedure:
• Routine Leg edema and groin dissection
The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.		at time of surgery	No