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Clinical Trials/NCT03877627
NCT03877627
Unknown
Not Applicable

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

Second Affiliated Hospital of Wenzhou Medical University0 sites60 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometrial Carcinoma
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Enrollment
60
Primary Endpoint
the number (s) of pelvic and abdominal lymph node metastasis
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
April 1, 2023
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

the number (s) of pelvic and abdominal lymph node metastasis

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

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