Hysteroscopic Guided Endometrial Sampling: Prospective Comparison Between 5Fr and 7Fr Biopsy Forceps (HYSTEROBIO)
试验速览
- 阶段
- 不适用
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- To evaluate ability to give a pathologic conclusion after 5Fr and 7Fr forceps biopsies
研究概览
简要总结
Indication for hysteroscopic guided biopsy compared to blind biopsy have been little evaluated. However, this kind of biopsy is usually performed in many centre. They allow exploration of uterine cavity but also to perform guided biopsies on the most suspicious area. However, with 5Fr forceps, biopsy are often too small to conclude.
详细描述
Blind biopsies using Novak or Cormier cannula had limits. Demirkiran et al conclude on 673 women that histology was similar between biopsies and hysterectomy in only 67% of cases. Others studies conclude thatit is difficult to conclude about focal disease with blind biopsies.
A study compared blind biopsies to biopsy performed under hysteroscopic guidance in women using Tamoxifene and conclude that guided biopsies were more specific (80% versus 68.9%) and a better positive predictive value (68.9% versus 43.7%) for all kind of endometrial pathologies
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Woman over 18 year-old with abnormal uterine bleeding (or endometrium thickness over 10mm) and risk factors of endometrial carcinoma, or endometrium thickness over 5mm in a menopausal woman or abnormal uterine bleeding after 45 years old.
- •Woman who speak and understand french
- •Woman who give her written informed consent
- •Woman covered by french medical insurance
排除标准
- •• Pregnant or breastfeeding patient
- •Patient under guardianship, curators or safeguard of justice.
- •Patient participating in another ongoing study.
结局指标
主要结局
To evaluate ability to give a pathologic conclusion after 5Fr and 7Fr forceps biopsies
时间窗: During the pathologist's analysis
Evaluated by the number of cases on witch the biopsy allowed to conclude
次要结局
- To compare rate of ability to obtain pathologic conclusion on the sample after 5Fr and 7Fr forceps in endometrial carcinoma(During the pathologist's analysis)
- To evaluate the rate of hysteroscopic failure due to cervical stenosis(During the pathologist's analysis)
- To compare histologic conclusions after 5 and 7Fr biopsies(During the pathologist's analysis)