The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy
试验速览
- 阶段
- 不适用
- 入组人数
- 560
- 试验地点
- 1
- 主要终点
- positive rate of biopsy
研究概览
简要总结
This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy
详细描述
This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy 560 patients were enrolled. The main result is the positive rate of biopsy: including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer.Secondary results include: (1)Biopsy complications include (infection, bleeding, etc.).(2)Pain score of biopsy patients (NRS score).(3) Biopsy time
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Randomly assign patient groups according to the random number method.The biopsy sample inspector does not know the patient's biopsy method
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Suspected prostate cancer patients Can tolerate prostate puncture
排除标准
- •Symptomatic acute or chronic inflammation of the prostate Patients with other cancers
结局指标
主要结局
positive rate of biopsy
时间窗: 1 year
Including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer
次要结局
- Biopsy time(1 year)
- Biopsy complications include (infection, bleeding, etc.)(1 year)
- Pain score of biopsy patients (NRS score)(1 year)