Sentinel lymph node technique in early-stage ovarian cancer (SENTOV): a phase II clinical trial

OBJECTIVE: Early-stage ovarian cancer might represent an ideal disease scenario for sentinel lymph node application. Nevertheless, the published experience seems to be limited. Our objective was to assess the feasibility and safety concerns of sentinel lymph node biopsy in patients with clinical stage I–II ovarian cancer. METHODS: We conducted a prospective cohort study of 20 patients with histologically confirmed ovarian cancer. (99m)Tc and indocyanine green were injected into both the utero-ovarian and infundibulopelvic ligament stump, if they were present, during surgical staging. An intraoperative gamma probe and near-infrared fluorescence imaging were used to detect the sentinel lymph nodes. Inclusion criteria included: >18 years of age, suspicious adnexal mass (unilateral or bilateral) at ultrasound and CT imaging or confirmed ovarian tumor after previous surgery (unilateral or bilateral salpingo-oophorectomy with or without hysterectomy). Adverse events were recorded through postoperative day 30. The primary trial end point was to report adverse events related to the technique, including the use of (99m)Tc and ICG intraperitoneally, as well as the feasibility of the technique. RESULTS: A total of 20 patients were included in the analysis. Sentinel lymph nodes were detected in 14/15 (93%) pelvic and all 20 (100%) para-aortic regions. Five patients did not have utero-ovarian injection because of prior hysterectomy. The mean time from injection to sentinel lymph node resection was 53±15 min (range; 30–80). The mean number of harvested sentinel lymph nodes was 2.2±1.5 (range; 0–5) lymph nodes in the pelvis and 3.3±1.8 (range; 1–7) lymph nodes in the para-aortic region. There were no adverse intraoperative events, nor any within the 30 days of follow-up related with the technique. CONCLUSION: Sentinel lymph node mapping in early-stage ovarian cancer is feasible without major intraoperative or < 30 days safety concerns. (NCT03452982). TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT03452982.