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

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900104
• Other study ID #: CEIN
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: February 2020
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 15, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Sentinel Lymph Node

Intervention

Procedure:
• Transcervical 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
• Cervical 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.

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Niikura H, Kaiho-Sakuma M, Tokunaga H, Toyoshima M, Utsunomiya H, Nagase S, Takano T, Watanabe M, Ito K, Yaegashi N. Tracer injection sites and combinations for sentinel lymph node detection in patients with endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):299-303. doi: 10.1016/j.ygyno.2013.08.018. Epub 2013 Aug 27. — View Citation

Solima E, Martinelli F, Ditto A, Maccauro M, Carcangiu M, Mariani L, Kusamura S, Fontanelli R, Grijuela B, Raspagliesi F. Diagnostic accuracy of sentinel node in endometrial cancer by using hysteroscopic injection of radiolabeled tracer. Gynecol Oncol. 2012 Sep;126(3):419-23. doi: 10.1016/j.ygyno.2012.05.025. Epub 2012 May 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detected pelvic and paraaortic sentinel lymph node numbers	Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)	Postoperative 30 days
Secondary	Numbers adverse events	Number of adverse events associated with the surgery	Postoperative 90 days