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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sentinel lymph node mapping with One injection site (cervix) group | Active Comparator | injecting indocyanine green (ICG) dye Intraoperative in cervix |
|
| sentinel lymph node mapping with two injection site (cervix-uterus) group | Experimental | injecting indocyanine green (ICG) dye Intraoperative in cervix and uterus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injecting indocyanine green (ICG) dye Intraoperative | Procedure | injecting indocyanine green (ICG) dye Intraoperative for patients with endometrial cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| paraaortic Sentinel lymph node detection rates | IGC positive Sentinel lymph node detection in paraaoritc lymph node will be assessed | intraoperative day0 |
| Sentinel lymph node technique accuracy | Sensitivity and specificity measure of the sentinel lymph node for detecting the lymphatic metastasis | postoperative up to day7 |
| Measure | Description | Time Frame |
|---|---|---|
| Optimizing Sentinel lymph node detection procedure in endometrium cancer | Optimizing injectiong site, tow site injection vs one site injection | intraoperative day 0 |
| The difference Sentinel lymph node detection rate with Double Injection Sites and one injection site |
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Inclusion Criteria:
• 1.Age >18 and <80 years old
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Peng, PhD | Contact | 86-18560088205 | jin_peng@outlook.com | |
| Youzhong Zhang, PhD | Contact | 86-18560081866 | zhangyouzhong@vip.sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital,Shandong University | Recruiting | Jinan | Shandong | 250012 | China |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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The study design is a two-arm, randomized, controlled trial.
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assessing difference IGC positive sentinel lymph node detection rate with Double Injection Sites and one injection site |
| intraoperative day 0 |
| Postoperative complications | Postoperative complications including damage of insestine , urethra and bladder | postoperative up to day 30 |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |