The aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.
Systematic pelvic and paraaortic lymphadenectomy is commonly performed in ovarian cancer patients. However, in early ovarian cancer systematic lymphadenectomy can be an unnecessary procedure which can cause perioperative morbidity and mortality. In the other hand, initially diagnosed early stage ovarian cancer can be upstaged after staging surgery with systematic lymphadenectomy. For preventing unnecessary lymphadenectomy in early ovarian cancer, sentinel lymph node procedure may be an alternative which can prevent major complications without missing the real stage of the disease. Aim of our study is to assess the feasibility and accuracy of lymph node evaluation with sentinel lymph node technique in early ovarian cancer patients. Pelvic and paraaortic spaces will be evaluated for the sentinel lymph nodes after the injection of the tracers in infundibulopelvic and utero-ovarian ligaments. Than routine systematic pelvic and paraaortic lymphadenectomy will be performed with the routine practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
Tracer (Indocyanine green or blue dye) will be injected into the IP and utero-ovarian ligaments, after opening of the pelvic and paraaortic retroperitoneal spaces, sentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice.
Acibadem MAA University Maslak Hospital
Istanbul, Turkey (Türkiye)
RECRUITINGSentinel lymph node localization
Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified.
Time frame: 12 months
Sentinel lymph node technique accuracy in ovarian cancer
Sensitivity and specificity measure of the sentinel lymph node procedure in ovarian cancer for detecting the lymphatic metastasis
Time frame: 12 months
PPV and NPV of sentinel lymph node procedure in ovarian cancer
Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer.
Time frame: 12 months
Adverse events
Adverse events related with sentinel lymph node procedure in ovarian cancer
Time frame: 12 months
Sentinel lymph node detection rate
Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer.
Time frame: 12 months
Tracer comparisons
Detection rate differences between different tracers
Time frame: 12 months
Assessment of the sentinel tecniques
Evaluation of the tracer injection techniques whether before the excision of the mass or after the excision of the mass for the effectiveness of sentinel lymph node detection.
Time frame: 12 months
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