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Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer
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Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.
Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.
Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.
An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.
As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.
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226 participants in 1 patient group
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Jan Persson, ass professor; Linnea Ekdahl, MD
Data sourced from clinicaltrials.gov
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