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

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.

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

Conditions
-----------------
Endometrial Cancer, Sentinel Lymph Node

Intervention / Treatment
-----------------
* Procedure: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles
* Procedure: Cervical injection of technetium 99 m-labeled human albumin colloid particles


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detected pelvic and paraaortic sentinel lymph node numbers | 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 | Number of adverse events associated with the surgery | Postoperative 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometrial Cancer, Sentinel Lymph Node, Paraaortic nodes involvement