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

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Brief Title

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

Official Title

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

Brief Summary

      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.

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

Primary Outcome

Detected pelvic and paraaortic sentinel lymph node numbers

Secondary Outcome

 Numbers adverse events

Condition

Endometrial Cancer

Intervention

Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles

Study Arms / Comparison Groups

 Transcervical endometrial injection arm
Description:  Tracer injection performed by a transcervical catheter in endometrial cancer patients.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

81

Start Date

May 1, 2019

Completion Date

January 15, 2020

Primary Completion Date

January 1, 2020

Eligibility Criteria

        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

Gender

Female

Ages

18 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Şener Gezer, M.D, ,

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations

NCT ID

NCT03900104

Organization ID

CEIN

Responsible Party

Principal Investigator

Study Sponsor

Kocaeli University

Study Sponsor

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

Verification Date

February 2020