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

Not Applicable

Completed

• Conditions: Sentinel Lymph Node; Endometrial Cancer
• Interventions: Procedure: Cervical injection of technetium 99 m-labeled human albumin colloid particles; Procedure: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles

• Registration Number: NCT03900104
• Lead Sponsor: Kocaeli University

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 Timeline

• Study First Submitted: 2019-03-31
• Study First Submitted QC: 2019-03-31
• Study First Posted: 2019-04-02
• Study Start: 2019-05-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical injection arm	Cervical injection of technetium 99 m-labeled human albumin colloid particles	Tracer injection was administered via the cervical route in endometrial cancer patients.
Transcervical endometrial injection arm	Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles	Tracer injection performed by a transcervical catheter in endometrial cancer patients.

Primary Outcome Measures

Name	Time	Method
Detected pelvic and paraaortic sentinel lymph node numbers	Postoperative 30 days	Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)

Secondary Outcome Measures

Name	Time	Method
Numbers adverse events	Postoperative 90 days	Number of adverse events associated with the surgery

Trial Locations

Locations (1)

Kocaeli University; 🇹🇷 Kocaeli, Turkey