Background: Systematic para-aortic and bilateral pelvic lymphadenectomy is included in the standard comprehensive surgical staging in presumed early epithelial ovarian cancer. No prospective randomized evidence suggests it has potential therapeutic value, and related morbidity is not negligible.
Primary objectives: To assess sensitivity, safety, and feasibility of the sentinel lymph node technique in identifying the presence of lymph node metastases in patients with early stage epithelial ovarian cancer.
Study hypothesis: Sentinel lymph node detection with indocyanine green can accurately predict nodal status in a cohort of women with early stage epithelial ovarian cancer.
Trial design: The SELLY trial is a prospective phase II interventional multicenter study.
Major inclusion/exclusion criteria: Inclusion criteria: Eastern Cooperative Oncology Group 0-1, apparent International Federation of Gynecology and Obstetrics (FIGO) stage I-II, histologically proven epithelial ovarian cancer.
Exclusion criteria: evidence of carcinomatosis, mucinous only at definitive histology.
Endpoints: Primary endpoint is sensitivity (true positive rate). Secondary endpoints include safety (complications rate of the procedure) and feasibility.
Sample size: Assuming a sensitivity of 98.5% in predicting positive sentinel lymph nodes at histology, a pathological lymph node prevalence of 14.2%, a precision of estimate (ie, the maximum marginal error) d=5%, and a type I error α=0.05, a sample size of 160 patients is needed to test the general hypothesis (ie, to answer whether sentinel lymph nodes identified with indocyanine green can accurately predict nodal status at histology of patients with apparently early epithelial ovarian cancer). Assuming a drop-out rate of 10%, a total of 176 patients will be enrolled in the study.
Estimated dates for completing accrual and presenting results: The accrual should be completed by December 2020 and results should be presented by March 2021.
Trial registration: The trial is registered at clinicaltrials.gov (NCT03563781).
Keywords: early ovarian cancer; indocyanine green (ICG); laparoscopy; lymphadenectomy; minimally-invasive surgery; sentinel node.
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