Endometrial Neoplasm Clinical Trial
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara University School of Medicine Department of Ob&Gyn | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity and specificity of sentinel lymph node frozen section | 6 months | No | |
Primary | Unilateral or bilateral sentinel lymph node detection rate by indocyanine green | 6 months | No | |
Secondary | Negative and positive predictive values for sentinel lymph node frozen section | 6 months | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00750672 -
Follow-up Care After Treatment for Endometrial Cancer
|
N/A |