Uterine Manipulation During Minimally Invasive Surgery for Early Stage Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 278
- 试验地点
- 10
- 主要终点
- Positive peritoneal cytology (PC)
研究概览
简要总结
This is a prospective, multi-center, randomized non-inferiority phase III study to evaluate if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.
详细描述
In most cases, patients who have early stage endometrial cancer undergo a surgery to remove the uterus, cervix, tubes, ovaries, and occasionally lymph nodes. This is usually done through a minimally invasive (not a large incision) surgery. To accomplish this, the uterus needs to be manipulated (moved around) to help the surgeon complete your surgery. This is usually done with a device called a uterine manipulator and the majority of surgeons use this device in any patient undergoing a minimally invasive hysterectomy (removal of the uterus and cervix).
Even though the majority of surgeons use a manipulator, there are some surgeons who believe there is a possibility that cancer cells inside the uterus can be spilled into the abdomen through the fallopian tubes. This may cause a higher risk of spreading the cancer and or of the cancer coming back.
Currently, there are very limited research studies directly looking at whether the uterine manipulator may cause these cells to appear in the abdomen.
The purpose of this study is to see if patients undergoing a minimally invasive surgery for early stage uterine cancer have cancer cells in the fluid that is obtained at the time of their surgery when a uterine manipulator is placed versus patients who do not have a uterine manipulator placed.
A computer program will randomly assign the subjects to one of two groups. One group will have minimally invasive surgery with the use of a uterine manipulator and the other group will have minimally invasive surgery without the use of a uterine manipulator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A subject will be considered eligible for inclusion in this study if all the following criteria are met:
- •Patient must be greater than or equal to 18 years old.
- •Suspected clinically early stage endometrial cancer of any histology (endometrioid, mixed, serous, clear-cell, carcinosarcomas, mucinous)
- •Pre-operative imaging not suggestive of extra-uterine disease, if obtained pre-operatively.
- •CA 125 testing is optional but, if obtained, must be within lab normal values.
- •ECOG performance status 0-2 (see appendix 1).
- •6. Signed informed consent and ability to comply with follow-up.
- •Per the opinion of the treating investigator, the patient must be a suitable candidate for the MIS surgical procedure.
排除标准
- •A subject must not have any of the following criteria:
- •Planned laparotomic hysterectomy
- •On progesterone therapy to treat their endometrial cancer
- •Any prior pelvic irradiation
结局指标
主要结局
Positive peritoneal cytology (PC)
时间窗: Immediately after uterine manipulator placement in the manipulator group or prior to the initiation of the hysterectomy procedure in the non-manipulator group
Positive PC is defined as the presence of malignant cells in the peritoneal cytology specimen.
次要结局
- Lymphovascular space invasion (LVSI)(During surgery)
- Operative time(1 day)
- Post-operative positive PC(Immediately after closure of the vaginal cuff)
- Percentage of myometrial invasion (MI)(During surgery)
- Extent of lymph node metastases(During surgery)
- Surgical morbidity(Intra-operative and up to 30 days post-surgery)
研究者
Anthony Costales, MD
Assistant Professor Obstetrics & Gynecology
Baylor College of Medicine