Sentinel Node Detection in Cervical Cancer
试验速览
- 阶段
- 不适用
- 发起方
- Region Skane
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol
研究概览
简要总结
Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer
详细描述
Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.
Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.
Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.
An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.
As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of age 18 years and older at the time of informed consent.
- •Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery
- •Absence of any exclusion criteria
排除标准
- •Non consenting patients
- •Ongoing pregnancy
- •Inability to understand written and/or oral study information
- •Who performance status III or more
- •Previous lower limb lymphedema
- •Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
- •Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
- •Locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography
- •Radiologically suspect pelvic nodal metastatic disease according to the RECIST criteria (>= 1 node with >=16 mm short axis diameter)
- •Allergy to Iodine
- •Patients with a known liver disease
- •Patients with a significant bleeding disorder or mandatory antithrombotic treatment.
研究组 & 干预措施
prospective cohort study
Prospective cohort study with detection of sentinel lymph nodes followed by a full pelvic lymphadenectomy. Patients will act as their own controls.
The intervention is the detection and removal of sentinel lymph nodes
干预措施: Sentinel node detection in cervical cancer (Procedure)
结局指标
主要结局
Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol
时间窗: 4-5 years
Detection of Sentinel nodes followed by full pelvic lymphadenectomy
次要结局
未报告次要终点