跳至主要内容
临床试验/NCT06004908
NCT06004908尚未招募不适用

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

Assiut University0 个研究点目标入组 36 人开始时间: 2023年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
主要终点
comparison between pre-biopsy MRI based diagnosis and histopathological proved diagnosis in cases of post-menopausal vaginal bleeding

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: baseline

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kholoud Khaled Salem Ali

Assistant lecturer

Assiut University

相似试验