NCT04972682已完成不适用
Tailoring Postoperative Management Through Sentinel Lymph Node Biopsy in Low- and Intermediate-Risk Endometrial Cancer: a Prospective Open-label Single-arm Clinical Trial
Moscow City Oncology Hospital No. 622 个研究点 分布在 2 个国家目标入组 102 人开始时间: 2021年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Change in postoperative treatment strategy
研究概览
简要总结
While total hysterectomy without lymph node staging is standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors can necessitate additional interventions. Our study assesses the influence of sentinel lymph node (SLN) biopsy on postoperative decision-making.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Histologically verified low-grade endometrioid adenocarcinoma of the endometrium (G1-G2)
- •FIGO stage IA
- •FIGO stage IB and II when LND is contraindicated
- •No contraindications for surgery
- •Signed informed consent
排除标准
- •• Age <18 years
- •Presence of tumor spread outside the corpus uteri
- •Absence of tumor invasion into the myometrium
- •High-grade tumor (G3)
- •Bokhman type 2 tumor (e.g., clear cell adenocarcinoma, serous adenocarcinoma, carcinosarcoma, endometrial stromal sarcoma)
- •Preoperative treatment of endometrial cancer including radiotherapy, systemic chemotherapy, or hormone therapy
- •Prior pelvic or retroperitoneal LND
- •History of surgeries on the uterus and uterine appendages, with exceptions such as cesarean section, tubectomy, oophorectomy, ovarian resection, ovarian biopsy, and ovarian cauterization
- •Allergy to iodine-containing drugs
- •Contraindications to surgical treatment
- •Lack of signed informed consent
结局指标
主要结局
Change in postoperative treatment strategy
时间窗: Up to 3 weeks after surgery
The rate of change in postoperative treatment based on the SLNB results and postoperative histology (percentage). A change in postoperative treatment strategy is defined as any difference between treatment plans set by the tumor board before and after receiving the SLN biopsy information.
次要结局
- Adjustments in FIGO staging(Up to 3 weeks after surgery)
- Major postoperative morbidity(Up to 30 days after surgery)
- Bilateral SLN detection(At the end of the surgery - 1 day)
- The rate of intraoperative complications of SLN biopsy(At the end of the surgery - 1 day)
- Details of intraoperative complications of SLN biopsy(At the end of the surgery - 1 day)
- Time to pelvic recurrence(24 months after surgery)
- Postoperative mortality(Up to 30 days after surgery)
- Incidence of lymphedema(Up to 24 months after surgery)
- Pelvic recurrence rate(24 months after surgery)
研究者
研究点 (2)
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