Background A radical surgical approach represents the mainstay treatment for gynecological malignancy, and preoperative staging of ovarian cancer is crucial. Ultrasound evaluation is widely recognized as the gold standard technique for the characterization of ovarian masses due to a high sensitivity for malignancy. In addition, its accuracy in defining intra-abdominal ovarian cancer spread has been previously proposed.
Primary objective To analyze the agreement between preoperative ultrasound examination and laparoscopic findings in assessing the extension of intra-abdominal disease using six parameters as described by Fagotti’s score.
Study hypothesis When performed by expert examiners, ultrasound can be an accurate technique to assess tumor spread in ovarian cancer and therefore to predict surgical resectability.
Trial design This is a single-center prospective observational study. Patients with clinical and/or radiological suspicion of advanced ovarian or peritoneal cancer will be assessed with preoperative ultrasound and assigned a score based on the six Fagotti’s laparoscopic score parameters. Each parameter will then be correlated with laparoscopic findings.
Major inclusion/exclusion criteria Eligible patients include women 18–75 years of age with clinical and/or imaging suggestive of advanced ovarian or peritoneal cancer, and an ECOG performance status 0–3.
Primary endpoints Sensitivity and specificity of ultrasound in detecting carcinomatosis, using the parameters of Fagotti’s score as a reference standard. Agreement between preoperative ultrasound examination and laparoscopic findings in assessing the extension of intra-abdominal disease as described in Fagotti’s score.
Sample size 240 patients.
Estimate dates for completing accrual and presenting results The accrual started in January 2019. Enrollment should be completed approximately by October 2020 and the results will be analyzed by December 2020.
Trial registration The study received the Ethical Committee approval on July 19 2018 (Protocol 28967/18 ID:2172).
- ovarian cancer
- peritoneal cavity
- peritoneal neoplasms
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Contributors Maria Cristina Moruzzi and Giulia Bolomini: conception and design study, manuscript preparation. Moro Francesca and Floriana Mascilini: data analysis and interpretation, statistical analysis. Ficarelli Silvia, Maria Teresa Giudice, Giuliana Beneduce: data collection and patients' recruitment. Anna Fagotti and Giovanni Scambia: responsible surgeons. Antonia Carla Testa: responsible for ultrasound.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial, or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement There are no data in this work.