Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer: A Prospective Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kocaeli University
- Enrollment
- 81
- Locations
- 1
- Primary Endpoint
- Detected pelvic and paraaortic sentinel lymph node numbers
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Transcervical endometrial injection arm
Tracer injection performed by a transcervical catheter in endometrial cancer patients.
Intervention: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles (Procedure)
Cervical injection arm
Tracer injection was administered via the cervical route in endometrial cancer patients.
Intervention: Cervical injection of technetium 99 m-labeled human albumin colloid particles (Procedure)
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Numbers adverse events(Postoperative 90 days)
Investigators
Şener Gezer
Principal Investigator
Kocaeli University