Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstituto de Investigacion Sanitaria La Fe

About this trial

This clinical trial investigates the sentinel lymph node (SLN) technique as a less invasive alternative to conventional lymphadenectomy in patients with early-stage ovarian cancer. The primary objective is to evaluate the effectiveness, safety, and diagnostic accuracy of the SLN approach in detecting lymphatic metastases. By assessing its negative predictive value, the study aims to determine whether the SLN technique can reliably replace systematic pelvic and paraaortic lymphadenectomy. If successful, this technique could minimize surgical morbidity, shorten hospitalization stays, and lower complication rates, ultimately improving patient outcomes.

Eligibility criteria

Qualifiers

Signed informed consent prior to the performance of any procedure related to the clinical trial.

Female, 18 years of age or older at the time of inclusion.

Patients with a histopathological diagnosis of malignant ovarian tumor in a deferred study (any epithelial histology), in apparent early stage FIGO I-II, proposed for staging surgery, or patients with suspected malignant ovarian tumor in apparent early stage FIGO I-II, who will undergo exploratory laparotomy and operative biopsy, and if positive, will undergo staging surgery.

Disqualifiers

Failure to obtain informed consent or revocation of informed consent.

Under 18 years of age at the time of inclusion.

Previous history of vascular surgery on the aorta, vena cava, or pelvic vessels.

Previous pelvic or paraaortic lymphatic surgery.

Trial design

Treatments tested in this trial

  • Sentinel Node Technique

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

Instituto de Investigacion Sanitaria La Fe

Lead sponsor

Hospital Universitario La Fe

Collaborator

Hospital Clinic of Barcelona

Collaborator

Hospital Universitario 12 de Octubre

Collaborator

Hospital Universitario La Paz

Collaborator

Hospital General Universitario Gregorio Marañon

Collaborator

Quirón Madrid University Hospital

Collaborator

Hospital of Navarra

Collaborator

Hospital Son Espases

Collaborator

Hospital Universitari de la Vall de Hebron

Collaborator

Hospital Universitario Fundación Jiménez Díaz

Collaborator

Clinica Universidad de Navarra, Universidad de Navarra

Collaborator