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

October 27, 2020 updated by: Second Affiliated Hospital of Wenzhou Medical University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year during the perioperative period
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
1 year during the perioperative period
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
1 year during the perioperative period
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
1 year during the perioperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

March 15, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

March 10, 2019

First Submitted That Met QC Criteria

March 13, 2019

First Posted (Actual)

March 15, 2019

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2019-07-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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