6533b824fe1ef96bd1281545
RESEARCH PRODUCT
Sentinel-node biopsy in early stage ovarian cancer: a prospective multicentre study (SELLY)
Giovanni ScambiaStefano UccellaAnna FagottiCamilla NeroVito ChianteraFabio GhezziFrancesco CosentinoEnrico Vizzasubject
medicine.medical_specialtyearly ovarian cancermedicine.medical_treatmentearly ovarian cancer; indocyanine green (ICG); laparoscopy; lymphadenectomy; minimally-invasive surgery; sentinel node; Carcinoma Ovarian Epithelial; Cohort Studies; Female; Humans; Lymph Nodes; Lymphatic Metastasis; Neoplasm Staging; Ovarian Neoplasms; Prospective Studies; Sensitivity and Specificity; Sentinel Lymph Node; Sentinel Lymph Node BiopsySentinel lymph nodelaparoscopyCarcinoma Ovarian EpithelialSensitivity and SpecificityCohort Studiesindocyanine green (ICG)Ovarian EpithelialBiopsymedicineClinical endpointHumansProspective StudiesStage (cooking)Lymph nodeNeoplasm StagingOvarian Neoplasmsmedicine.diagnostic_testbusiness.industrySentinel Lymph Node BiopsyCarcinomaObstetrics and GynecologySentinel nodemedicine.diseaseearly ovarian cancer; indocyanine green (ICG); laparoscopy; lymphadenectomy; minimally-invasive surgery; sentinel nodeminimally-invasive surgerymedicine.anatomical_structureSettore MED/40 - GINECOLOGIA E OSTETRICIAOncologysentinel nodeLymphatic MetastasislymphadenectomyLymphadenectomyFemaleRadiologyLymph NodesSentinel Lymph NodebusinessOvarian cancerdescription
BackgroundSystematic 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 Objective(s)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 HypothesisSentinel lymph node detection with indocyanine green can accurately predict nodal status in a cohort of women with early stage epithelial ovarian cancer.Trial DesignThe SELLY trial is a prospective phase II interventional multicenter study.Major Inclusion/Exclusion CriteriaInclusion 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.Endpoint(s)Primary endpoint is sensitivity (true positive rate). Secondary endpoints include safety (complications rate of the procedure) and feasibility.Sample SizeAssuming 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 ResultsThe accrual should be completed by December 2020 and results should be presented by March 2021.Trial RegistrationThe trial is registered at clinicaltrials.gov (NCT03563781).
| year | journal | country | edition | language |
|---|---|---|---|---|
| 2019-01-01 |