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.
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.
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.
Single group
Sentinel Node Technique
Procedure/SurgeryA 0.2 ml (27 mBq) dose of 99mTc and 0.5 ml (1.25 mg/ml) of ICG is injected subperitoneally in the dorsal or ventral side of the pelvic infundibulum stump, and 0.2 ml (27 mBq) of 99mTc and 1 ml (1.25 mg/ml) of ICG intracervically. Sentinel nodes are located using the auditory signal from the gamma probe and visually via ICG staining with an infrared light system. After 30 minutes, all identified nodes are removed. Deferred histology applies ultra-staging for negative or micrometastatic nodes.
Negative predictive value of the sentinel lymph node technique.
To determine the negative predictive value of the sentinel lymph node technique for detecting lymph node metastases, using pelvic/aortic lymphadenectomy as the Gold Standard.
Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy
Evaluate the degree of concordance (sensitivity, specificity, positive predictive value, and diagnostic accuracy) between the sentinel lymph node technique and pelvic/aortic lymphadenectomy (Gold Standard) for detecting lymph node metastasis.
Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection
Characterize the sentinel lymph node technique for detecting lymph node metastasis using pelvic/aortic lymphadenectomy as the Gold Standard in terms of sensitivity, specificity, positive and negative predictive value, positive and negative likelihood ratios, and effectiveness.
Sample Characterization
Characterize the sample (through collection of baseline characteristics, medical history, tumor markers, intraoperative findings, surgical procedures, and immediate admission data).
Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection
Characterize the sentinel lymph node technique for detecting lymph node metastasis based on the site of drug injection, using lymphadenectomy as the Gold Standard, in terms of sensitivity, specificity, positive and negative predictive value, positive and negative likelihood ratios, and effectiveness.
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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
