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

Primary Purpose

Endometrial Cancer, Sentinel Lymph Node

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles
Cervical injection of technetium 99 m-labeled human albumin colloid particles
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrial Cancer focused on measuring Endometrial Cancer, Sentinel Lymph Node, Paraaortic nodes involvement

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Kocaeli University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transcervical endometrial injection arm

Cervical injection arm

Arm Description

Tracer injection performed by a transcervical catheter in endometrial cancer patients.

Tracer injection was administered via the cervical route in endometrial cancer patients.

Outcomes

Primary Outcome Measures

Detected pelvic and paraaortic sentinel lymph node numbers
Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)

Secondary Outcome Measures

Numbers adverse events
Number of adverse events associated with the surgery

Full Information

First Posted
March 31, 2019
Last Updated
February 18, 2020
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT03900104
Brief Title
Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer
Official Title
Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer: A Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer, Sentinel Lymph Node
Keywords
Endometrial Cancer, Sentinel Lymph Node, Paraaortic nodes involvement

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcervical endometrial injection arm
Arm Type
Experimental
Arm Description
Tracer injection performed by a transcervical catheter in endometrial cancer patients.
Arm Title
Cervical injection arm
Arm Type
Active Comparator
Arm Description
Tracer injection was administered via the cervical route in endometrial cancer patients.
Intervention Type
Procedure
Intervention Name(s)
Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Cervical injection of technetium 99 m-labeled human albumin colloid particles
Intervention Description
Cervical injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery.
Primary Outcome Measure Information:
Title
Detected pelvic and paraaortic sentinel lymph node numbers
Description
Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)
Time Frame
Postoperative 30 days
Secondary Outcome Measure Information:
Title
Numbers adverse events
Description
Number of adverse events associated with the surgery
Time Frame
Postoperative 90 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şener Gezer, M.D
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22659192
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.
Results Reference
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PubMed Identifier
23988415
Citation
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.
Results Reference
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Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer

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