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

Terminated

• Conditions: Vulvar Cancer
• Interventions: Procedure: Routine Leg edema and groin dissection

• Registration Number: NCT01321697
• Lead Sponsor: University of Arkansas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-06-10
• Status Verified: 2013-08
• Results First Submitted QC: 2013-08-23
• Last Update Submitted: 2013-08-23
• Results First Posted: 2013-08-27
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vulvar Cancer	Routine Leg edema and groin dissection	-

Primary Outcome Measures

Name	Time	Method
Successful Identification of Vulvar Sentinel Lymph Nodes Via Gamma Probe.	at time of surgery

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States