Ovarian masses are uncommon in children, with an estimated annual incidence of
2.6/100,000. They are most identified in the neonatal period or around the time of
menarche. Most ovarian cysts are benign and 55-70% of which are mature cystic teratomas.
In most cases, patients are asymptomatic and the ovarian lesions are incidentally
detected through ultrasound examinations. However, up to 15% of cases may involve
abdominal pain and torsion. Furthermore, despite the low incidence of ovarian cancer
(less than 1% of all pediatric cancers), the possibility of malignant tumor must be
addressed.
In 2018, a national survey of pediatric surgeons in the UK revealed significant
variability in the strategies employed for investigating and surgically managing adnexal
lesions in children and adolescents. Although there is a spread consensus that ultrasound
indices are useful for distinguishing between benign and malignant lesions in pediatric
patient, the evidence available for this specific population is limited and it lacks
comprehensive data from large cohorts. Moreover, existing models developed by the
International Ovarian Tumor Analysis (IOTA) group, such as the Simple Rules, Benign
Descriptors, and ADNEX model, have not been validated in this younger population.
Additionally, it is still unclear if these tools remain validated with a transabdominal
approach, primarily used for children and non-sexually active adolescents.
The primary objective of this prospective study is therefore to assess the performance of
these existing ultrasonography-based risk tools in discriminating between benign and
malignant adnexal masses in neonates, young girls and adolescents using transabdominal
and/or transvaginal ultrasound.
Secondary aims are the diagnostic accuracy of subjective assessment by ultrasound, the
understanding of the natural history of adnexal masses at 6-8 weeks, 3 months, and 12
months and the assessment of the complications rate (such as rupture, torsion, or
malignancy) in patients treated conservatively.
Final outcome will be based on pathology in patients who undergo surgery and on pattern
recognition, i.e. subjective assessment of ultrasound examiner, in patients managed
conservatively for masses where morphology remains unchanged during follow-up.
The study will be conducted over a minimum of two years. We anticipate recruiting 1000
surgically managed masses over a 24-month period.