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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03900104

Enrollment

Registered

2019-04-02

Start date

2019-05-01

Completion date

2020-01-15

Last updated

2020-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer, Sentinel Lymph Node

Keywords

Endometrial Cancer, Sentinel Lymph Node, Paraaortic nodes involvement

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.

Interventions

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

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

PROCEDURECervical injection of technetium 99 m-labeled human albumin colloid particles

Cervical injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Detected pelvic and paraaortic sentinel lymph node numbers	Postoperative 30 days	Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)

Secondary

Measure	Time frame	Description
Numbers adverse events	Postoperative 90 days	Number of adverse events associated with the surgery

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026