The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Clinical Significance of Sentinel Lymph Node Imaging Combined With Imaging Examination in Pelvic and Peritoneal Lymphadenectomy for Endometrial Carcinoma

Conditions
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Endometrial Carcinoma, Lymphadenectomy

Intervention / Treatment
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* Procedure: Pelvic and Peritoneal Lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females who are diagnosed with endometrial carcinoma; Patients who are willing to receive primary non-reserved fertility function surgery to treat their disease; Patients who are agreed to participated in this prospective cohort study. Exclusion Criteria: Patients who still have the will to have pregnancy; Patients who have other diseases or heavy injuries that will interfere with the results; Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 60 patients who were assessed negative by sentinel lymph node imaging combined with imaging were randomized to undergo pelvic and peritoneal lymphadenectomy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Negative 1<br>Patients in this arm will not undergo Pelvic and Peritoneal Lymphadenectomy. | |
| Experimental: Negative 2<br>Patients in this arm will undergo Pelvic and Peritoneal Lymphadenectomy. | Procedure: Pelvic and Peritoneal Lymphadenectomy<br>* Patients in arm 2 will be randomized to undergo pelvic and peritoneal lymphadenectomy to treat their endometrial carcinoma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |