The researchers are doing this study to see if giving people fluorescein sodium as an IV infusion before their vulvectomy for treating extramammary Paget's disease (EMPD) can help surgeons with performing the procedure. The researchers will look at whether fluorescein sodium helps surgeons identify disease cells that should be removed. Other purposes of this study include looking at the following: If there are any complications during or after vulvectomy involving the use of fluorescein sodium. If fluorescein sodium can reveal tissue that surgeons cannot operate on (unresectable tissue).
Age ≥18 years
Noninvasive or microinvasive EMPD with a contiguous visible clinical lesion
Newly diagnosed or recurrent lesion
Scheduled to undergo wide local excision or vulvectomy not requiring resection of the clitoris, urethra, or anus and with the surgeon's judgment that primary closure is possible (V-Y advancement flap closure is allowed)
History of allergic reaction to fluorescein sodium
Multifocal, noncontiguous clinical lesion
Current or previous invasive EMPD
History of invasive vulvar, vaginal, or anal cancer
Single group
Fluorescein Sodium
DrugPatients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.
rate of positive pathologic surgical margin status
is to determine whether the use of IV fluorescein sodium reduces the rate of positive surgical margins in patients undergoing vulvectomy for EMPD. The incidence of positive surgical margins on final pathology will be evaluated as the primary endpoint;
incidence of intraoperative or postoperative complications
all intraoperative and postoperative complications (including allergic reactions to fluorescein sodium injection, allergic reaction, infection, wound breakdown, need for reoperation) in the study population will be recorded prospectively. All complications of grade 3 or higher, as defined by Martin et al.10
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