A Single-Arm Prospective Trial of Fluorescein Mapping in Patients Undergoing Vulvectomy for Extramammary Paget's Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 27
- 试验地点
- 14
- 主要终点
- rate of positive pathologic surgical margin status
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •History of allergic reaction to fluorescein sodium
- •Multifocal, noncontiguous clinical lesion
- •Current or previous invasive EMPD
- •History of invasive vulvar, vaginal, or anal cancer
- •Lesion in which resection of the clitoris, urethra, and/or anus is deemed to be necessary
- •Lesion in which a primary closure or V-Y advancement flap is believed not to be possible and a larger myocutaneous flap is needed for closure of the defect
- •History of radiation therapy to the vulva and/or anus
研究组 & 干预措施
Undergoing Vulvectomy for Extramammary Paget's Disease (EMPD)
Consented patients will receive IV fluorescein sodium in the operating room before the vulvectomy procedure.
干预措施: Fluorescein Sodium (Drug)
结局指标
主要结局
rate of positive pathologic surgical margin status
时间窗: 1 year
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;
次要结局
- incidence of intraoperative or postoperative complications(up to 30 days post op)