Indocyanine Green Versus Blue Dye for Detection of Sentinel Lymph Node In Endometrial Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- the difference in the proportion of hemipelves with successful detection of SLN according to the dye used
研究概览
简要总结
To determine the difference in the proportion of hemipelves with successful detection of Sentinel Lymph Node according to the dye used (indocyanine green with near-infrared imaging vs blue dye) in women with endometrial cancer.
详细描述
In the past few years, Sentinel Lymph Node (SLN) procedure has emerged as an interesting solution to the debate on lymphadenectomy in endometrial cancer. Using blue-dye is inexpensive but results in an unsatisfactory detection rate of SLN. IndoCyanine Green (ICG) with near-infrared imaging is a novel technology for SLN mapping and initial reports on the use of ICG have shown high detection rate. In the present study, we aim to determine precisely the increase in detection rate of SLN associated with the use of ICG instead of blue dye. This randomized controlled trial will include patients with preoperative stage I endometrial carcinoma. All included women will undergo SLN mapping with blue dye in one hemipelvis and ICG in the other hemipelvis. Randomization will concern the side of the hemipelvis in which blue dye vs ICG mapping is used, so that the patient's contralateral hemipelvis will serve as a control to her ipsilateral hemipelvis. The primary endpoint is the difference in the proportion of hemipelves with successful detection of SLN according to the dye used. The unique precise information gained from the present study will contribute to determine whether the benefit of the use of ICG over blue dye is sufficient to justify the expense of its use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •all patients with endometrial carcinoma proven by endometrial biopsy or curettage AND
- •preoperative FIGO (International Federation of Gynecology and Obstetrics) stage I AND
- •intended for staging via laparoscopic or robotic surgery AND
- •Patients must be older than 18 year-old, able to read French or English.
排除标准
- •preoperative FIGO stages II to IV
- •previous pelvic or paraaortic lymphadenectomy or radiotherapy
- •surgery that could change the uterine lymphatic drainage (myomectomy)
- •iodine allergy
- •pregnancy.
结局指标
主要结局
the difference in the proportion of hemipelves with successful detection of SLN according to the dye used
时间窗: at time of surgery
次要结局
未报告次要终点
