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
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