A Prospective, Randomized Trial Comparing the Different Injection Sites of Indocyanine Green (ICG) in Sentinel Lymph Node Mapping in Patients With Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- paraaortic Sentinel lymph node detection rates
研究概览
简要总结
The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing different method performed in patients with endometrial cancer. The aim of this study is to investigate whether the detection rate of sentinel lymph node (SLN) with two different injection sites may be increased compared to the standard use with single site (cervix) injection in endometrial cancer.
详细描述
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 if sentinel lymph node is positive.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• 1.Age >18 and <80 years old
- •The pathological diagnosis was epithelial ovarian cancer
- •3.Survival time is expected to exceed 3 months
- •4.Signed consent form
排除标准
- •Patients with myocardial infarction or stroke, or unstable angina pectoris or decompensated heart function
- •2.Patients with a history of exhaustion or deep vein thrombosis;
- •Liver insufficiency (transaminase >2.5 times the upper limit of the standard);
- •Renal insufficiency (serum muscle liver >2 times the standard upper limit);
- •Pregnancy and perinatal patients;
- •History of major organ transplantation and immune disease;
- •Psychiatric condition or language barriers
- •Alcohol or drug abuser (current or previous)
- •Unable or unwilling to sign informed consent or comply with study requirements;
- •Patients with other malignant tumors.
结局指标
主要结局
paraaortic Sentinel lymph node detection rates
时间窗: intraoperative day0
IGC positive Sentinel lymph node detection in paraaoritc lymph node will be assessed
Sentinel lymph node technique accuracy
时间窗: postoperative up to day7
Sensitivity and specificity measure of the sentinel lymph node for detecting the lymphatic metastasis
次要结局
- Optimizing Sentinel lymph node detection procedure in endometrium cancer(intraoperative day 0)
- The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site(intraoperative day 0)
- Postoperative complications(postoperative up to day 30)
研究者
Youzhong Zhang
chief of OB&G department
Qilu Hospital of Shandong University