The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer

Study Overview
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Brief Summary
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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.

Conditions
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Endometrial Neoplasm

Intervention / Treatment
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* Procedure: Sentinel lymph node mapping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sentinel lymph node mapping<br>Sentinel lymph node mapping with indocyanine green injection to cervix in endometrial cancer patients operated laparoscopically | Procedure: Sentinel lymph node mapping<br>* 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.<br>* Other names: Indocyanine green, PULSION medical systems;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative and positive predictive values for sentinel lymph node frozen section |  | 6 months |