Endometrial Neoplasm
Conditions
Brief summary
Endometrial cancer is the most common gynecologic malignancy in developed countries and the second one in developing countries following cervical cancer. The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be performed. The secondary purpose of the study is to compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer patients.
Interventions
PROCEDURESentinel lymph node mapping
Before laparoscopic hysterectomy and lymphadenectomy procedure for endometrial cancer, Indocyanine green solution will be injected through cervix. Then the surgeon will look for sentinel lymph nodes under fluorescence visualization.
Sponsors
Ankara University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pathologic diagnosis of endometrial cancer * Clinical stage I or II
Exclusion criteria
* Contraindications for operation (hematological or coagulation disorders) * Advanced stage * Pregnancy or puerperium * Fertility preserving surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of sentinel lymph node frozen section | 6 months |
| Unilateral or bilateral sentinel lymph node detection rate by indocyanine green | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Negative and positive predictive values for sentinel lymph node frozen section | 6 months |
Countries
Turkey (Türkiye)
Contacts
Primary ContactSalih Taşkın, Assoc. Prof.
Outcome results
None listed