Ovarian Cancer, Sentinel Lymph Node
Conditions
Brief summary
The aim of the study to evaluate the feasibility and accuracy of sentinel lymph node technique in ovarian cancer.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTSentinel lymph node detection
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.
Sponsors
Acibadem University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective, Controlled, not randomized
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Early stage ovarian cancer
Exclusion criteria
* Patient who had been administrated chemotherapy prior to surgery * Patients who had diagnosed with malignancy other than ovarian cancer. * Patients who had undergone pelvic or paraaortic lymphadenectomy or surgery prior to surgery. * Patients who have allergy for the tracers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sentinel lymph node localization | 12 months | Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified. |
| Sentinel lymph node technique accuracy in ovarian cancer | 12 months | Sensitivity and specificity measure of the sentinel lymph node procedure in ovarian cancer for detecting the lymphatic metastasis |
| PPV and NPV of sentinel lymph node procedure in ovarian cancer | 12 months | Positive predictive and negative predictive value of sentinel lymph node procedure in ovarian cancer. |
| Adverse events | 12 months | Adverse events related with sentinel lymph node procedure in ovarian cancer |
| Sentinel lymph node detection rate | 12 months | Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tracer comparisons | 12 months | Detection rate differences between different tracers |
| Assessment of the sentinel tecniques | 12 months | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactOzguc Takmaz, Assist.Prof
Outcome results
None listed