One-stop clinical assessment of risk for endometrial hyperplasia (OSCAR-Endo): a fast-track protocol for evaluating endometrial pathologies
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To evaluate a one-stop clinical assessment of risk for assessing endometrial pathologies (OSCAR-Endo), consisting of a fast-track protocol with hysteroscopy, dilation and curettage (D&C) with intraoperative frozen section analysis of the removed tissue in cases of hysteroscopic suspicion of malignancy.
In this prospective clinical trial, a total of 304 consecutive women with sonographically suspected endometrial hyperplasia and/or postmenopausal bleeding, underwent D&C with intraoperative frozen section analysis between May 2013 and September 2015. Based on the results of the hysteroscopy and/or frozen section, the OSCAR-Endo score was reported: negative, when no frozen section was regarded necessary or the frozen section yielded a negative result; equivocal, when the frozen section reported an equivocal result; positive, when frozen section reported either complex hyperplasia with atypia or cancer.
Frozen sections were required by the surgeons in 59 (19.4%) of cases. When compared with the final histology after D&C, frozen section showed a sensitivity, specificity, PPV, NPV, and overall test accuracy of 91.3, 100, 100, 94.1, and 96.3% for predicting malignant disease, respectively. The OSCAR-Endo score showed a sensitivity, specificity, PPV, NPV, and overall test accuracy of 84, 100, 100, 98.6, and 98.7% for predicting malignant disease, respectively.
The OSCAR-Endo protocol is easy to perform in daily clinical practice reaching an excellent test accuracy. It helps in immediate postoperative counseling of affected patients.
Clinical Trial Registration http://www.clinicaltrials.gov; NCT01961102.
KeywordsHysteroscopy Frozen section Endometrial cancer Endometrial pathology D&C
KH-F was responsible for protocol/project development, data collection and management, data analysis, manuscript writing/editing. EH-G was responsible for protocol/project development, manuscript writing/editing. VU was responsible for data collection and management, data analysis, manuscript writing/editing. JL was responsible for protocol/project development, data collection and management, manuscript writing/editing. GB-P was responsible for data collection and management, manuscript writing/editing. FM was responsible for data collection and management, protocol/project development, manuscript writing/editing. LH was responsible for protocol/project development, data analysis, manuscript writing/editing.
Compliance with ethical standards
No funding has been received for the present study.
Conflict of interest
All authors have no actual or potential conflict of interest including any financial, personal or other relationships with other people or organizations within 2 years of beginning the submitted work that could inappropriately influence, or be perceived to influence, their work to disclose.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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