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Clinical Trial Summary

The aim of the study is to determine the diagnostic performance of MRI of endometrial pathology in postmenopausal women with postmenopausal bleeding


Clinical Trial Description

Postmenopausal bleeding is a common clinical problem accounting for approximately 5% of office visits to a general gynecologist. Postmenopausal bleeding has been defined as: 1. Vaginal bleeding occurring at least 6 months after complete cessation of menses in women not on hormonal replacement therapy (HRT). 2. Noncyclic vaginal bleeding occurring in postmenopausal women who are receiving HRT Abnormal vaginal bleeding may be caused by a number of gynecologic or nongynecologic disorders. When evaluating a gynecologic etiology, the primary goal is to eliminate the possibility of endometrial cancer which is the cause of bleeding in approximately 10% of postmenopausal women presenting with this complaint and is the presenting symptom in 90% of women with endometrial cancer. Other common gynecologic etiologies include endometrial polyps, endometrial hyperplasia, and submucosal fibroids along with the use of hormone replacement therapy, tamoxifen, and phytoestrogens Those pathologies should be discriminated to navigate the treatment process. Transvaginal ultrasonography (TVS) is the most efficient first-step technique for diagnosis of postmenopausal bleeding . The sensitivity of TVS to detect endometrial pathologies is high, but its specificity is low . Therefore, biopsy is recommended as a second-step diagnostic method when endometrial thickness exceeds 4 mm . However, endometrial biopsy or dilatation and curettage (D&C) may not be possible in postmenopausal patients due to endometrial atrophy, endometrial adhesions, or the requirement of general anesthesia. . Furthermore, besides pain and discomfort with endometrial sampling procedures, in some occasions such as vaginal/cervical stenosis or pelvic organ prolapse these procedures may be difficult to be done . Additionally, blind sampling may not be an effective approach for diagnosis of focal endometrial lesions and may be subject to sampling error . MRI is an emerging modality for various reasons, such as exquisite soft-tissue resolution, its capability of multiplanar imaging, characterization, high sensitivity, and lack of ionizing radiation. The sensitivity of MRI in identifying acute uterine pathologies is 96.6 % With recent advances in MR imaging techniques, diffusion weighted (DW) imaging and ADC value are useful in characterization of endometrial lesions because malignant lesions show high cellularity with little extracellular space which give restricted motion of water molecules and lower ADC values in contrast to benign lesions and normal tissues . ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06004908
Study type Observational
Source Assiut University
Contact kholoud khaled salem, graduated
Phone 01050111754
Email Kkholod676@gmail.com
Status Not yet recruiting
Phase
Start date October 1, 2023
Completion date November 1, 2024

See also
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