跳至主要内容
临床试验/NCT04246580
NCT04246580已完成不适用

Evaluation of Indocyanine Green-guided Systematic Pelvic Lymphadenectomy in Endometrial and Cervical Cancer

Università degli Studi dell'Insubria0 个研究点目标入组 230 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
230
主要终点
Retrieved lymph nodes

研究概览

简要总结

The lymph nodes involvement is one of the most important prognostic factors in endometrial (EC) and cervical cancer (CC). Indeed, the lymph node involvement in cancer patients modifies the International Federation of Gynecology and Obstetrics (FIGO) stage and plays a pivotal role in the choice of the adjuvant therapy.

Since the modern imaging techniques are not yet able to accurately detect lymph nodes metastasis, pelvic systematic lymphadenectomy has still an important role and it still represents the gold standard in EC and CC. The sentinel lymph node (SLN) biopsy, which is a standard practice in breast cancer and melanoma, is often used in some early stage gynaecological cancers such as EC and CC.

Indocyanine green (ICG) is the most used tracer for the detection of SLN in gynaecological cancer, especially in laparoendoscopic setting. ICG allows a complete visualization of the lymphatic drainage and, for this reason, it may be used even in systematic pelvic lymphadenectomy to guide the surgeon during the procedure. Several studies have demonstrated an advantage of the ICG-guided lymphadenectomy in other types of cancers, showing a higher number of lymph nodes removed with this technique when compared to standard lymphadenectomy (without ICG).

To date, there is no published study about ICG-guided systematic pelvic lymphadenectomy in EC and CC. In this scenario, the aim of this study will be to compare systematic ICG-guided pelvic lymphadenectomy and standard lymphadenectomy in EC and CC.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women affected by endometrial or cervical cancer
  • Laparoscopic/robotic surgical approach with systematic pelvic lymphadenectomy.

排除标准

  • Women undergoing open surgery (laparotomy) for the surgical management of endometrial or cervical cancer.

结局指标

主要结局

Retrieved lymph nodes

时间窗: At the moment of the surgery

Number of retrieved lymph nodes after laparoscopic/robotic systematic pelvic lymphadenectomy

次要结局

未报告次要终点

研究者

发起方
Università degli Studi dell'Insubria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Simone Laganà

Principal Investigator

Università degli Studi dell'Insubria

相似试验