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
Åžener 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
Åžener Gezer, M.D, Principal Investigator, Kocaeli University
Verification Date
February 2020