Pelvic peritOnectomy iN Early Stage Ovarian Tumors: a prospEctive Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants).
研究概览
简要总结
Early-stage ovarian tumors represent approximately 30% of all newly diagnosed ovarian cancers. Current international guidelines recommend random peritoneal biopsies for surgical staging, but the diagnostic yield of these biopsies remains limited. The PONDER study aims to evaluate whether standardized surgical procedure and pathology assessment of wider peritoneal pelvic biopsies can increase the detection rate of microscopic peritoneal implants and micrometastases in patients with early-stage ovarian tumors. This multicenter, prospective, single-arm study includes both minimally invasive and open surgical approaches, with a standardized gross and microscopic evaluation of the resected peritoneal specimens
详细描述
The study focuses on the excision of anatomically defined pelvic peritoneal areas, with meticulous dissection of the retroperitoneal spaces and a nerve-sparing approach. Combined with a specific pathology protocol, this strategy improves the detection of microscopic peritoneal involvement and provides new insights into the mechanisms of pelvic recurrence
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •FIGO 2018 stage IA-IB epithelial or non-epithelial ovarian or fallopian tube tumors
- •Complete preoperative work-up (ultrasound, CT scan, tumor markers)
- •Laparoscopic, robotic or open surgical approach
- •Signed informed consent
排除标准
- •Sarcomas, melanomas, mesotheliomas, hematologic malignancies
- •Advanced ovarian tumors
- •Fertility-sparing surgery with uterine preservation
- •Inability to provide informed consent
结局指标
主要结局
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants).
时间窗: from surgery up to at least 24 months of follow up after surgery
Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants)
次要结局
- Perioperative complications(from the date of surgery up to six months after surgery)
- Recurrence site(from the date of surgery up to at least 24 months of follow up)
- 2-year progression free survival(24 months after surgery)
- 2-year overall survival(24 months after surgery)
研究者
Elena Olearo
MD
Ospedale Santa Croce-Carle Cuneo