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临床试验/NCT02822833
NCT02822833Unknown不适用

The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer

Ankara University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Unilateral or bilateral sentinel lymph node detection rate by indocyanine green

研究概览

简要总结

Endometrial cancer is the most common gynecologic malignancy in developed countries and the second one in developing countries following cervical cancer. The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be performed. The secondary purpose of the study is to compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer patients.

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

  • •Pathologic diagnosis of endometrial cancer
  • •Clinical stage I or II

排除标准

  • •Contraindications for operation (hematological or coagulation disorders)
  • •Advanced stage
  • •Pregnancy or puerperium
  • •Fertility preserving surgery

研究组 & 干预措施

Sentinel lymph node mapping

Experimental

Sentinel lymph node mapping with indocyanine green injection to cervix in endometrial cancer patients operated laparoscopically

干预措施: Sentinel lymph node mapping (Procedure)

结局指标

主要结局

Unilateral or bilateral sentinel lymph node detection rate by indocyanine green

时间窗: 6 months

Sensitivity and specificity of sentinel lymph node frozen section

时间窗: 6 months

次要结局

  • Negative and positive predictive values for sentinel lymph node frozen section(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

salih taskin

Assoc. Prof.

Ankara University

研究点 (1)

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