Fibroid Clinical Trial
Official title:
Advantages of Ulipristal Acetate for the Preoperative Treatment of Hypoechoic Cellular Leiomyomas
Cellular leiomyomas (CLs) are described as leiomyomas that are significantly more cellular than the surrounding myometrium, often with crowding and overlapping of nuclei. they often are soft and appear more tan or yellow and less circumscribed than the usual leiomyomas. Pre-operatively CLs can be recognized at ultrasound evaluation because they appear as hypoechoic uterine lesions. patients with hypoechoic myoma have a significantly longer surgery time after treatment with a gonadotropin-releasing hormone (GnRH) analog probably related to degenerative changes induced by this treatment. Hypoechoic CLs should be more responsive to ulipristal acetate treatment than common leiomyomas. The antiproliferative ulipristal effect, moreover, induces a condition of apoptotic necrosis that, compared to GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of the tumor.
Rationale why study should be conducted: Leiomyomas are the most common benign neoplasm in
women; it has been estimated that these tumors occur in at least 25% of all women, which is
probably an underestimation, because this figure is based on a select population. They are
histologically composed by smooth muscle cells with bland, uniform, cigar-shaped nuclei that
are arranged in interlacing bundles, showing little or no mitotic activity. Cellular
leiomyomas (CLs) are described as leiomyomas that are significantly more cellular than the
surrounding myometrium, often with crowding and overlapping of nuclei.
The presenting symptoms do not differ from those of patients with typical leiomyomas. On
gross examination, CLs are more often soft and appear more tan or yellow and less
circumscribed than the usual leiomyomas.
Pre-operatively, anyway, CLs can be recognized at ultrasound evaluation because they appear
as hypoechoic uterine lesions. It has been demonstrated that patients with hypoechoic myoma
have a significantly longer surgery time after treatment with a GnRH analog than for the
rest of the pretreated fibroids or the untreated patients with hypoechoic myomas.
Considering the predominant relevance of the traction maneuvers in laparoscopic myomectomy,
the difficulty in adequately grasping the tumor is the key element in the longer operative
time. The greater softening of the fibroid tissue is probably related to degenerative
changes induced by the GnRH-analog pretreatment, particularly in those fibroids without an
adequate fibrous "skeleton" and thus with the appearance as hypoechoic at the admission
ultrasonography. From a pathologic point of view, these fibroids, when pretreated, showed a
predominance of areas of coagulative necrosis and mixoid degeneration, causing longer
operative time and showing unequivocally the negative effect of preoperative GnRH analog
treatment for these kinds of uterine fibroids.
At the same time, hypoechoic CLs should be more responsive to ulipristal acetate treatment
than common leiomyomas, given its antiproliferative activity in cultured leiomyoma cells.
The antiproliferative ulipristal effect, moreover, induces a condition of apoptotic necrosis
that, compared to GnRH-a myxoid necrosis, probably allows an easier surgical enucleation of
the tumor.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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