Randomized Controlled Trial on the Oncologic Outcomes of Use Versus Not Use of the Uterine Manipulator in the Surgical Treatment of Apparent Uterine-confined Endometrial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,030
- 试验地点
- 5
- 主要终点
- Recurrence-free survival
研究概览
简要总结
Minimally invasive surgery is the recommended approach in endometrial cancer (EC) patients based on the results of two randomized controlled trials, given its advantages without compromised oncologic outcomes. The uterine manipulator is commonly used in benign and malignant pathologies to perform a laparoscopic or robotic hysterectomy. However, although regularly used, the uterine manipulator adoption in EC is a controversial technical aspect due to the raised concerns regarding the possible risk of disruption of the tumor mass, the spread of malignant cells, and seeding of the disease, particularly at the level of the vaginal cuff or spread of tumor cells, with increased risk of recurrence and death due to EC. On that basis, given that hysterectomy without a uterine manipulator is feasible, only a randomized controlled trial comparing oncologic outcomes in EC patients after use versus not use of the uterine manipulator will be able to provide high-quality evidence to answer this critical question and allow or exclude the use of a uterine manipulator during minimally invasive hysterectomy for EC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Endometrial Cancer of any histology (including carcinosarcoma) and grade
- •Planned surgical treatment including hysterectomy and bilateral salpingo-oophorectomy (ovarian preservation in selected patients is not an exclusion criterion)
- •Age ≥ 18 years
- •No preoperative evidence of extrauterine disease (Clinical stage IIIA, IIIB)
- •No preoperative evidence of suspicious lymph nodes (Clinical stage IIIC)
- •No preoperative evidence of distant metastasis (Clinical stage IV)
- •Approved and signed informed consent
排除标准
- •Neoadjuvant therapy
- •Synchronous or previous (< 5 years) invasive cancer, not including non-melanoma skin cancer
- •Fertility preservation
- •World Health Organization performance score > 2
- •Uterine sarcoma
- •Previous pelvic/abdominal radiotherapy, hormone therapy for cancer (< 5 years), chemotherapy (< 5 years), pelvic or paraaortic lymphadenectomy, or retroperitoneal surgery
- •Inadequate bone marrow function (white blood cells <3·0×109/L, platelets <100×109/L)
- •Inadequate liver function (bilirubin >1.5×upper normal limit [UNL], aspartate aminotransferase, and alanine aminotransferase >2.5 × UNL)
- •Inadequate kidney function (creatinine clearance < 60 mL per min calculated according to Cockcroft-Gault 10 or < 50 mL per min Ethylenediaminetetraacetic acid clearance)
- •Intraoperative evidence of stage IV disease
结局指标
主要结局
Recurrence-free survival
时间窗: Each follow-up visit, up to 4 years from the day of surgery
Any recurrence or death related to endometrial cancer (EC) or treatment
次要结局
- Operative time(Day of surgery)
- Peritoneal cytology(Day of surgery)
- 30-day post-surgical morbidity(30 days after surgery)
- Overall survival(Each follow-up visit, up to 4 years from the day of surgery)
- Intraoperative blood loss(Day of surgery)
- Cause-specific survival(Each follow-up visit, up to 4 years from the day of surgery)
- Site-specific recurrence-free survival(Each follow-up visit, up to 4 years from the day of surgery)
- Lymphovascular space invasion(Day of surgery)
- Quality of life indexes(Each follow-up visit, up to 4 years from the day of surgery)
研究者
Stefano Uccella
Prof. Stefano Uccella
Universita di Verona