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

Endometrial Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03877627
• Other study ID #: SAHoWMU-CR2019-07-102
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: October 2020
• Source: Second Affiliated Hospital of Wenzhou Medical University
• Contact: Yu ZHAO, Ph.D
• Phone: 13777760306
• Email: zhaoyu196035[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 1, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 10 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Endometrial Carcinoma
• Endometrial Neoplasms
• Lymphadenectomy

Intervention

Procedure:
• Pelvic and Peritoneal Lymphadenectomy
Patients in arm 2 will be randomized to undergo pelvic and peritoneal lymphadenectomy to treat their endometrial carcinoma.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Wenzhou Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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