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Sentinel lymph node technique in early-stage ovarian cancer (SENTOV): a phase II clinical trial
  1. Victor Lago1,2,3,
  2. Pilar Bello4,
  3. Beatriz Montero5,
  4. Luis Matute1,
  5. Pablo Padilla-Iserte1,
  6. Susana Lopez5,
  7. Tiermes Marina1,
  8. Marc Agudelo4 and
  9. Santiago Domingo1
  1. 1Gynecologic Oncology Department, University Hospital La Fe, Valencia, Spain
  2. 2Woman’s Health Research Group, Medical Research Institute La Fe (IISLAFE), Valencia, Spain
  3. 3Spanish Clinical Research Network, SCReN-IIS La Fe (PT17/0017/0035), Valencia, Spain
  4. 4Nuclear Medicine Department, University Hospital La Fe, Valencia, Spain
  5. 5Pathology Department, University Hospital La Fe, Valencia, Spain
  1. Correspondence to Dr Victor Lago, Gynecologic Oncology Department, University Hospital La Fe, Av. Fernando Abril Martorell, Tower F, 3rd Floor, 46026, Valencia, Spain; victor.lago.leal{at}hotmail.com

Abstract

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. 99mTc 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 99mTc 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.

  • sentinel lymph node
  • ovarian cancer
  • surgical oncology
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Footnotes

  • Correction notice Since the online publication of this article, the title has been updated to include the acronym 'SENTOV'.

  • Collaborators Marta Gurrea Soteras and Teresa Viñas Alburquerque.

  • Contributors VL: Conception and design of study, data collection, surgeon, statistical analysis, data analysis and interpretation, manuscript preparation. PB: Conception and design of study, nuclear medicine specialist, data analysis and interpretation, reviewer. BM: Conception and design of study, pathologist review, data analysis and interpretation, reviewer. LM: Surgeon, statistical analysis, data analysis and Interpretation, reviewer. PP-I: Surgeon, statistical analysis, data analysis and interpretation, reviewer. SL: Pathologist review, data analysis and interpretation, reviewer. TM: Surgeon, statistical analysis, data analysis and interpretation, reviewer. MA: Nuclear medicine specialist, statistical analysis, data analysis and interpretation, reviewer. SD: Conception and design of study, data collection, surgeon, statistical analysis, data analysis and interpretation, reviewer.

  • Funding This study was funded by Precipita (Crowdfunding) and the SCReN (Spanish Clinical Research Network; SCIII-Subdirección General de Evaluación y Fomento de la Investigación: PT17/0017/0035).

  • Competing interests SD has received a speaker honorarium from Ethicon.

  • Patient consent for publication Not required.

  • Ethics approval Obtained; EUDRACT code: 2017-003683-12

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All relevant data are included in the article, nevertheless the full data of the article will be available upon reasonable request.

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