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


Journal

International journal of gynecological cancer : official journal of the International Gynecological Cancer Society
ISSN: 1525-1438
Titre abrégé: Int J Gynecol Cancer
Pays: England
ID NLM: 9111626

Informations de publication

Date de publication:
09 2020
Historique:
received: 06 02 2020
revised: 18 03 2020
accepted: 23 03 2020
pubmed: 26 5 2020
medline: 2 10 2021
entrez: 26 5 2020
Statut: ppublish

Résumé

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. We conducted a prospective cohort study of 20 patients with histologically confirmed ovarian cancer. 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. Sentinel lymph node mapping in early-stage ovarian cancer is feasible without major intraoperative or < 30 days safety concerns. (NCT03452982). ClinicalTrials.gov, NCT03452982.

Identifiants

pubmed: 32448808
pii: ijgc-2020-001289
doi: 10.1136/ijgc-2020-001289
pmc: PMC7497563
doi:

Banques de données

ClinicalTrials.gov
['NCT03452982']
EudraCT
['2017-003683-12']

Types de publication

Clinical Trial, Phase II Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1390-1396

Informations de copyright

© IGCS and ESGO 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.

Déclaration de conflit d'intérêts

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

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Auteurs

Victor Lago (V)

Gynecologic Oncology Department, University Hospital La Fe, Valencia, Spain victor.lago.leal@hotmail.com.
Woman's Health Research Group, Medical Research Institute La Fe (IISLAFE), Valencia, Spain.
Spanish Clinical Research Network, SCReN-IIS La Fe (PT17/0017/0035), Valencia, Spain.

Pilar Bello (P)

Nuclear Medicine Department, University Hospital La Fe, Valencia, Spain.

Beatriz Montero (B)

Pathology Department, University Hospital La Fe, Valencia, Spain.

Luis Matute (L)

Gynecologic Oncology Department, University Hospital La Fe, Valencia, Spain.

Pablo Padilla-Iserte (P)

Gynecologic Oncology Department, University Hospital La Fe, Valencia, Spain.

Susana Lopez (S)

Pathology Department, University Hospital La Fe, Valencia, Spain.

Tiermes Marina (T)

Gynecologic Oncology Department, University Hospital La Fe, Valencia, Spain.

Marc Agudelo (M)

Nuclear Medicine Department, University Hospital La Fe, Valencia, Spain.

Santiago Domingo (S)

Gynecologic Oncology Department, University Hospital La Fe, Valencia, Spain.

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Classifications MeSH