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Completed

NCT Number: NCT03900104

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Sentinel Lymph Node Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kocaeli University

Kocaeli, 41380, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

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

Procedure

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

Primary outcomes

  1. 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

  1. Numbers adverse events

    Time frame: Postoperative 90 days

    Number of adverse events associated with the surgery

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2019
Registry last updated
Feb 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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