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

Not Applicable

• Conditions: Lymphadenectomy; Endometrial Carcinoma
• Interventions: Procedure: Pelvic and Peritoneal Lymphadenectomy

• Registration Number: NCT03877627
• Lead Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-03-10
• Study First Submitted QC: 2019-03-13
• Study First Posted: 2019-03-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29
• Study Start: 2022-04-01
• Primary Completion: 2023-03-15
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Females who are diagnosed with endometrial carcinoma;
2. Patients who are willing to receive primary non-reserved fertility function surgery to treat their disease;
3. Patients who are agreed to participated in this prospective cohort study.

Exclusion Criteria

1. Patients who still have the will to have pregnancy;
2. Patients who have other diseases or heavy injuries that will interfere with the results;
3. Simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative 2	Pelvic and Peritoneal Lymphadenectomy	Patients in this arm will undergo Pelvic and Peritoneal Lymphadenectomy.

Primary Outcome Measures

Name	Time	Method
the number (s) of pelvic and abdominal lymph node metastasis	1 year during the perioperative period	the specific number of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma
the percentage (%) of pelvic and abdominal lymph node metastasis	1 year during the perioperative period	the specific percentage of pelvic and abdominal lymph nodes that are invaded by metastatic endometrial carcinoma
the coincidence rate (%) of pelvic and abdominal lymph node imaging, sentinel lymph node imaging and pathological diagnosis	1 year during the perioperative period	by performing chi-square test by SPSS 17.0，we plan to calculate the coincidence rate of three clinical examination
the effect of pelvic lymphadenectomy on the prognosis of endometrial carcinoma patients	1 year during the perioperative period	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