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Clinical Trials/NCT06004908
NCT06004908
Not yet recruiting
Not Applicable

Role of MRI in Diagnosis of Causes of Postmenopausal Bleeding in Correlation to Histopathological Results

Assiut University0 sites36 target enrollmentOctober 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postmenopausal Bleeding
Sponsor
Assiut University
Enrollment
36
Primary Endpoint
comparison between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed 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 .

Registry
clinicaltrials.gov
Start Date
October 1, 2023
End Date
November 1, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kholoud Khaled Salem Ali

Assistant lecturer

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Any female patient after menopause suffering from vaginal bleeding.
  • Patients receiving tamoxifen with vaginal bleeding.
  • Patient had histopathological biopsy examination either by total hysterectomy, hysteroscopy or D \&C.
  • Patient must have local cause

Exclusion Criteria

  • Patients not amenable for MRI examination
  • Patients not in menopause
  • Patients have general bleeding tendency
  • Patients not underwent histopathological biopsy examination

Outcomes

Primary Outcomes

comparison between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding

Time Frame: baseline

anaylsis between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding

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