Qilu Hospital,Shandong University
Jinan, Shandong, 250012, China
Location status: Recruiting
NCT Number: NCT06656949
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.
Interested in participating?
Request Info18 year–80 year
Female
Interventional
Not applicable
Jinan, Shandong, 250012, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
injecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer
Time frame: intraoperative day0
IGC positive Sentinel lymph node detection in paraaoritc lymph node will be assessed
Time frame: postoperative up to day7
Sensitivity and specificity measure of the sentinel lymph node for detecting the lymphatic metastasis
Time frame: intraoperative day 0
Optimizing injectiong site, tow site injection vs one site injection
Time frame: intraoperative day 0
assessing difference IGC positive sentinel lymph node detection rate with Double Injection Sites and one injection site
Time frame: postoperative up to day 30
Postoperative complications including damage of insestine , urethra and bladder
Contact information is provided by the study sponsor or research team.
Jin Peng, PhD
CONTACT
Youzhong Zhang, PhD
CONTACT
Qilu Hospital of Shandong University
Other
A Prospective, Randomized Trial Comparing the Different Injection Sites of Indocyanine Green (ICG) in Sentinel Lymph Node Mapping in Patients With Endometrial Cancer
Acronym: SLN-EC-01
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