The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Ankara University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Unilateral or bilateral sentinel lymph node detection rate by indocyanine green
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Unilateral or bilateral sentinel lymph node detection rate by indocyanine green
Time Frame: 6 months
Sensitivity and specificity of sentinel lymph node frozen section
Time Frame: 6 months
Secondary Outcomes
- Negative and positive predictive values for sentinel lymph node frozen section(6 months)
Investigators
salih taskin
Assoc. Prof.
Ankara University
