Ultrasound-based Anatomo-Surgical Classification of Liver-Area Involvement in Ovarian Cancer (HERCULES Study): A Feasibility and Methodology Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of standardized 2D ultrasound for liver-area anatomo-surgical classification
研究概览
简要总结
This monocentric observational pilot study aims to assess the feasibility of a standardized two-dimensional ultrasound (2D US) approach for the preoperative assessment and anatomo-surgical classification of liver-area involvement in women with advanced or recurrent epithelial ovarian cancer. The study will evaluate whether standardized ultrasound acquisition and reporting can identify the main patterns of liver-area disease and assign them to predefined surgical classes. In patients with parenchymal lesions, the study will also explore the ability of ultrasound to differentiate liver peritoneal infiltration from hematogenous hepatic metastases. Clinical, ultrasound, surgical, and histological data will be collected from a retrospective and prospective cohort. Ultrasound findings will be compared with surgical findings, with histology used as an additional reference standard when available. The study will also develop a standardized ultrasound acquisition protocol and reporting template to improve reproducibility and support preoperative surgical planning.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Women aged ≥18 years.
- •Suspicious or histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- •Suspicious primary FIGO stage III-IV disease or recurrent ovarian cancer undergoing complete cytoreductive surgery.
- •For participants included in the prospective cohort, written informed consent for study participation and processing of personal data.
- •For the retrospective cohort, eligible participants may include individuals for whom informed consent cannot be obtained because they are deceased or cannot be contacted despite all reasonable efforts to trace them. Data processing will be conducted in accordance with applicable Italian data protection regulations.
排除标准
- •- Previous radiotherapy involving the hepatic area
结局指标
主要结局
Feasibility of standardized 2D ultrasound for liver-area anatomo-surgical classification
时间窗: At baseline, before surgery
Proportion of enrolled patients with a complete and evaluable preoperative 2D ultrasound dataset allowing assignment of the anatomo-surgical class of liver-area involvement and, when parenchymal lesions are present, differentiation between liver peritoneal infiltration (LPI) and hematogenous hepatic metastases (HHM).
次要结局
- Adherence to the standardized 2D ultrasound acquisition protocol(At baseline, before surgery)
- Concordance between ultrasound findings and the anatomo-surgical classification(At surgery)