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The aim of this prospective cohort study is to explore the clinical significance of sentinel lymph node imaging combined imaging examination evaluation in pelvic and peritoneal lymphadenectomy for endometrial carcinoma management.
The clinical data including surgical procedure, the situation of sentinel lymph node imaging and pathological results of patients with endometrial carcinoma treated in our hospitals between April 2019 and April 2021 will be analyzed in this study to clarify the homogeneity of imaging evaluation, sentinel lymph node development evaluation and pathological results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative 1 | No Intervention | Patients in this arm will not undergo Pelvic and Peritoneal Lymphadenectomy. | |
| Negative 2 | Experimental | Patients in this arm will undergo Pelvic and Peritoneal Lymphadenectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic and Peritoneal Lymphadenectomy | Procedure | Patients in arm 2 will be randomized to undergo pelvic and peritoneal lymphadenectomy to treat their endometrial carcinoma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the number (s) of pelvic and abdominal lymph node metastasis | the specific number of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma | 1 year during the perioperative period |
| the percentage (%) of pelvic and abdominal lymph node metastasis | the specific percentage of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma | 1 year during the perioperative period |
| the coincidence rate (%) of pelvic and abdominal lymph node imaging, sentinel lymph node imaging and pathological diagnosis | by performing chi-square test by SPSS 17.0,we plan to calculate the coincidence rate of three clinical examination | 1 year during the perioperative period |
| the effect of pelvic lymphadenectomy on the prognosis of endometrial carcinoma patients | by setting up the control group and experimental group and conducting follow-up,we are determined to know whether pelvic lymphadenectomy would influence the prognosis of endometrial carcinoma | 1 year during the perioperative period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu ZHAO, Ph.D | Contact | 13777760306 | zhaoyu196035@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2019 |
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60 patients who were assessed negative by sentinel lymph node imaging combined with imaging were randomized to undergo pelvic and peritoneal lymphadenectomy.
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| Mar 8, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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