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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Lymph Node | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel lymph node detection | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sentinel lymph node localization | Localization areas of pelvic and paraaortic sentinel lymph nodes for ovarian cancer will be identified. | 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 | 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. | 12 months |
| Adverse events | Adverse events related with sentinel lymph node procedure in ovarian cancer | 12 months |
| Sentinel lymph node detection rate | Pelvic and paraaortic Sentinel lymph node detection rates will be assessed for ovarian cancer. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tracer comparisons | Detection rate differences between different tracers | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ozguc Takmaz, Assist.Prof | Contact | +905554006591 | ozguctakmaz@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mete Gungor, Prof. | Acibadem MAA University Maslak Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acibadem MAA University Maslak Hospital | Recruiting | Istanbul | 34457 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Prospective, Controlled, not randomized
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|
| 12 months |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |