跳至主要内容
临床试验/CTRI/2025/02/080627
CTRI/2025/02/080627招募中不适用

Comparison between ultrasound guided transperineal and transrectal prostate biopsy for suspected carcinoma prostate: a randomized controlled trial

Dr Jitendra Singh Rathor1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年2月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
To compare overall complications in TRUS guided transperineal and transrectal prostate biopsy.

研究概览

简要总结

TRUS guided transperineal biopsy (TPBx) and TRUS guided transrectal biopsy (TRBx) are the two primary approaches to obtain prostate tissue for diagnosis of PCa. Their main differences lie in the puncture site, puncture route and the TRUS transducer. In TPBx, the needle punctures through skin at the perineum under the guidance of a bi-planar transducer; while in TRBx, the needle punctures through the anterior rectal wall under the guidance of an end-fire transducer. Potential drawback of the transrectal approach includes the increased febrile postprocedural urinary tract infections (UTIs). In contrast, transperineal ultrasound-guided prostate biopsies (TPPBx) have been linked to increased postprocedural urinary retention rates, appear to be more invasive than TRPBx and cannot easily be delivered in an outpatient setting, as they often need general anesthesia or sedation. Thus with the introduction of local anesthesia such as pudendal nerve block and the adoption of freehand techniques have contributed to the feasibility of performing TP biopsy.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
Male

入选标准

  • PSA more than 4 ng/ml for two times Abnormal DRE Findings like hard or nodular prostate MP-MRI findings or PIRADS more than equal to 3.

排除标准

  • Patient Does not give consent Patients unfit for biopsy Previous history of Prostate biopsy.

结局指标

主要结局

To compare overall complications in TRUS guided transperineal and transrectal prostate biopsy.

时间窗: On the 7th and 15th day after biopsy, each patient will be scheduled for a telephone review to assess possible complications. Long-term follow-up will be performed on an “as-needed” basis

次要结局

  • (1) Adequacy of sample tissue retrieval in terms of presence of prostatic tissue, length of core & cancer detection rate

研究者

发起方
Dr Jitendra Singh Rathor
申办方类型
Other []
责任方
Principal Investigator
主要研究者

Dr Jitendra Singh Rathor

All India Institute of Medical Sciences, Jodhpur

研究点 (1)

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