JPRN-jRCTs031180426已完成2 期
Indocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory study
sui Hirokazu0 个研究点目标入组 46 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
研究概览
简要总结
The study was terminated before the targeted initial sample size. The detection rate of sentinel lymph nodes in this study was about 80.4% and 95%CI. The negative predictive value was 100%. There was no adverse event according to the injection of ICG. Although the number of cases was small, the negative predictive value was 100%, suggesting that lymph node dissection may be omitted in cases with negative sentinel lymph nodes.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 70age old（—）
- 性别
- Female
入选标准
- •1. Patients with endometrial cancer who are scheduled for retroperitoneal lymph node dissection or patients with stage 1A2 to 2A1 cervical cancer based on the International Federation of Gynecology and Obstetrics guidelines.
- •2. Over 20 years of age and under 70 years of age
- •3. Eastern Cooperative Oncology Group Performance status score 0-1
- •4. Patients who provide written informed consent
排除标准
- •1.Prior medical history of chemical sensitivity to indocyanine green
- •2.Detection of obvious lymph node swelling using CT or MRI
- •3.Extra-uterine dissemination
- •4.Patients on dialysis
- •5.Patients determine to be ineligible for any other reason by the physician in-charge
研究者
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