Sentinel Lymph Node Detection in Endometrial Cancer: A Consolidation Study
试验速览
- 阶段
- 不适用
- 发起方
- Region Skane
- 入组人数
- 362
- 试验地点
- 2
- 主要终点
- Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes
研究概览
简要总结
Evaluation of removal of Sentinel lymph nodes only for detection of pelvic lymph node metastases in high risk and low risk endometrial cancer.
详细描述
Consecutive patients with- and low risk endometrial cancer will be approached for eligibility for inclusion in a study evaluating the detection rates of pelvic metastatic disease by detection and removal of Sentinel lymph nodes only, i.e with no further lymphadenectomy.
A re-staging will be performed in case of metastatic Sentinel lymph nodes to guide adjuvant treatment.
The detection rate will be evaluated from a non-inferiority perspective against the expected rate of nodal metastases based on detailed final histological data.
Adverse events related the intervention ( Injection of tracer (ICG) and removal of sentinel nodes), time for the intervention, and an objective evaluation of lymphatic complications (lymphoedema) will be performed in addition to the use of a validated lymphoedema QOL questionnaire.
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 85 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 endometrial carcinoma of any histologic subtype or grade, clinically stage I-II planned for primary surgery
- •A uterine size allowing minimally invasive surgery
- •Women must be able to understand and sign an informed consent in Swedish language.
- •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 or conditions contraindicating adjuvant oncological treatment (WHO III or more)
- •Previous lower limb lymphedema ( only for the lymphedema part of study)
- •Evidence of locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography.
- •Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
- •Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
- •Allergy to Iodine
- •Patients with a known liver disease
- •Patients with a bleeding disorder or mandatory antithrombotic treatment.
研究组 & 干预措施
SLN only
Pelvic SLN's defined by ICG injected cervically
干预措施: Injection of tracer ( ICG) and detection of sentinel lymph nodes (Procedure)
结局指标
主要结局
Operative time used for the study intervention ( injection of ICG and identification and removal of sentinel lymph nodes
时间窗: 3 years from start inclusion
Exact measurements of time allocated for the SLN procedure as such.
Detection rate of pelvic metastatic disease in endometrial cancer
时间窗: 3 years from start inclusion with an interim analysis after 150 patients
The detection rate will be evaluated from a non-inferiority perspective based on a null-hypothesis of 4% less than an expected rate of 12% nodal metastases
次要结局
- intraoperative adverse events associated with the study intervention(3 years from start inclusion or after 150 patients if study stopped at interim analysis)
- Incidence of lymphedema after removal of sentinel lymph nodes(4 years including at least one year follow up)