Feasibility of Sentinel Node Mapping Using Indocyanine green (ICG)-in Early Epithelial Ovarian Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Conducting this study is essential to determine whether sentinel lymph node (SLN) mapping using indocyanine green (ICG) alone can serve as a safe, feasible, and cost-effective alternative to systematic lymphadenectomy in early-stage epithelial ovarian cancer. Establishing its diagnostic performance and reproducibility is the critical first step toward minimizing surgical morbidity while preserving oncologic accuracy. In the Indian context, where most patients belong to lower socioeconomic strata and extensive surgery increases both cost and postoperative complications, ICG-based SLN mapping offers a low-resource, minimally invasive approach that could deliver comparable staging accuracy with reduced morbidity and faster recovery, making this investigation timely and clinically relevant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •• Women aged more than eighteen years • Women with suspected/Histologically confirmed (frozen section acceptable) stage I-II epithelial ovarian/tubal/peritoneal carcinoma undergoing primary staging • No radiologically suspicious nodes (short-axis less than ten mm and no malignant morphology).
- •• Able to provide written informed consent.
排除标准
- •• Intra-operative finding of carcinomatosis/extra-ovarian disease before SLN injection (Stage IIIC /IV disease) • Previous surgery on one or both ovaries • Prior h/o cytoreductive surgery or neoadjuvant chemotherapy or recurrent disease • Presence of bulky nodes (more than two cm) • Non-epithelial histologies • Known allergy to ICG/iodine or prior anaphylaxis to contrast dyes.
- •• Previous history of RT for any malignancy.
研究者
Shagun Kapoor
All India Institute of Medical Sciences, New Delhi