Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer

February 18, 2020 updated by: Şener Gezer, Kocaeli University

Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer: A Prospective Randomized Trial

The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Endometrial tracer injection will be performed by cervical or transcervical endometrial methods. Pelvic and para-aortic sentinel lymph node detection capacity will be assessed in this study.

Study Type

Interventional

Enrollment (Actual)

81

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 Locations

  • Turkey
      • Kocaeli, Turkey, 41380
        • Kocaeli University

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Endometrial Cancer Patients
  • Suitable patients for surgical staging

Exclusion Criteria:

  • Patients who cannot undergo cervical or transcervical endometrial injection
  • Pathology did not confirm endometrial cancer
  • Sarcoma of the uterine corpus
  • If a 90-day follow-up was not feasible

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcervical endometrial injection arm
Tracer injection performed by a transcervical catheter in endometrial cancer patients.
Procedure: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles
Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery. Injection performed with a trans-cervical catheter
Active Comparator: Cervical injection arm
Tracer injection was administered via the cervical route in endometrial cancer patients.
Procedure: Cervical injection of technetium 99 m-labeled human albumin colloid particles
Cervical injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detected pelvic and paraaortic sentinel lymph node numbers
Time Frame: Postoperative 30 days
Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)
Postoperative 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers adverse events
Time Frame: Postoperative 90 days
Number of adverse events associated with the surgery
Postoperative 90 days

Collaborators and Investigators

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

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Şener Gezer, M.D, Kocaeli University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

May 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

March 31, 2019

First Submitted That Met QC Criteria

March 31, 2019

First Posted (Actual)

April 2, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEIN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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