The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy (SLNB) procedure by comparing different method performed in patients with endometrial cancer. The aim of this study is to investigate whether the detection rate of sentinel lymph node (SLN) with two different injection sites may be increased compared to the standard use with single site (cervix) injection in endometrial 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 if sentinel lymph node is positive.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
42
injecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer
Qilu Hospital,Shandong University
Jinan, Shandong, China
RECRUITINGparaaortic Sentinel lymph node detection rates
IGC positive Sentinel lymph node detection in paraaoritc lymph node will be assessed
Time frame: intraoperative day0
Sentinel lymph node technique accuracy
Sensitivity and specificity measure of the sentinel lymph node for detecting the lymphatic metastasis
Time frame: postoperative up to day7
Optimizing Sentinel lymph node detection procedure in endometrium cancer
Optimizing injectiong site, tow site injection vs one site injection
Time frame: intraoperative day 0
The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site
assessing difference IGC positive sentinel lymph node detection rate with Double Injection Sites and one injection site
Time frame: intraoperative day 0
Postoperative complications
Postoperative complications including damage of insestine , urethra and bladder
Time frame: postoperative up to day 30
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