Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer
NCT ID: NCT03900104
Last Updated: 2020-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
81 participants
INTERVENTIONAL
2019-05-01
2020-01-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Transcervical endometrial injection arm
Tracer injection performed by a transcervical catheter in endometrial cancer patients.
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 arm
Tracer injection was administered via the cervical route in endometrial cancer patients.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Suitable patients for surgical staging
Exclusion Criteria
* Pathology did not confirm endometrial cancer
* Sarcoma of the uterine corpus
* If a 90-day follow-up was not feasible
18 Years
90 Years
FEMALE
No
Sponsors
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Kocaeli University
OTHER
Responsible Party
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Şener Gezer
Principal Investigator
Principal Investigators
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Şener Gezer, M.D
Role: PRINCIPAL_INVESTIGATOR
Kocaeli University
Locations
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Kocaeli University
Kocaeli, , Turkey (Türkiye)
Countries
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References
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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.
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.
Other Identifiers
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CEIN
Identifier Type: -
Identifier Source: org_study_id
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