Endometrial Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREinjecting indocyanine green (ICG) dye Intraoperative
injecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The study design is a two-arm, randomized, controlled trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* • 1.Age \>18 and \<80 years old * 2\. The pathological diagnosis was epithelial ovarian cancer * 3.Survival time is expected to exceed 3 months * 4.Signed consent form
Exclusion criteria
* 1\. Patients with myocardial infarction or stroke, or unstable angina pectoris or decompensated heart function * 2.Patients with a history of exhaustion or deep vein thrombosis; * 3\. Liver insufficiency (transaminase \>2.5 times the upper limit of the standard); * 4\. Renal insufficiency (serum muscle liver \>2 times the standard upper limit); * 5\. Pregnancy and perinatal patients; * 6\. History of major organ transplantation and immune disease; * 7\. Psychiatric condition or language barriers * 8\. Alcohol or drug abuser (current or previous) * 9\. Unable or unwilling to sign informed consent or comply with study requirements; * 10\. Patients with other malignant tumors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| paraaortic Sentinel lymph node detection rates | intraoperative day0 | IGC positive Sentinel lymph node detection in paraaoritc lymph node will be assessed |
| Sentinel lymph node technique accuracy | postoperative up to day7 | Sensitivity and specificity measure of the sentinel lymph node for detecting the lymphatic metastasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Optimizing Sentinel lymph node detection procedure in endometrium cancer | intraoperative day 0 | Optimizing injectiong site, tow site injection vs one site injection |
| The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site | intraoperative day 0 | assessing difference IGC positive sentinel lymph node detection rate with Double Injection Sites and one injection site |
| Postoperative complications | postoperative up to day 30 | Postoperative complications including damage of insestine , urethra and bladder |
Countries
China
Contacts
Primary ContactJin Peng, PhD
Backup ContactYouzhong Zhang, PhD
Outcome results
None listed