HERCULES: Ultrasound-Based Liver Involvement Classification in Ovarian Cancer

Ultrasound-based Anatomo-Surgical Classification of Liver-Area Involvement in Ovarian Cancer (HERCULES Study): A Feasibility and Methodology Study

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

- Previous radiotherapy involving the hepatic area