Prostate Core Needle Biopsy

Not Applicable

Completed

• Conditions: Prostate; Complication; Biopsy
• Interventions: Device: coaxial prostate biopsy; Device: noncoaxial prostate biopsy

• Registration Number: NCT02756975
• Lead Sponsor: Modarres Hospital

Brief Summary

Prostate tissue biopsy is performed with either transrectal or transperineal approach. These two methods are usually based on tissue sampling with an ultrasound-guided core needle biopsy. Transperineal prostate biopsy can be done either with a conventional noncoaxial technique or with a coaxial technique. In conventional transperineal technique, biopsy needle is inserted repeatedly for each tissue sampling. Alternatively, a coaxial needle can be placed over the perineum; then, the direction of the biopsy can be changed by tilting the coaxial needle. In this prospective study, the investigators sought to compare the procedural time and the complication rate of coaxial technique with those of noncoaxial technique in transperineal prostate biopsy.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-02
• Study Completion: 2015-12
• Status Verified: 2016-04
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-04-27
• Last Update Submitted: 2016-04-27
• Study First Posted: 2016-04-29
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 240

Inclusion Criteria

• an elevated prostate-specific antigen (PSA) level
• suspicious digital rectal examination

Exclusion Criteria

• a history of prostate cancer
• clinical findings of acute or chronic prostate inflammation
• a history of urogenital procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transperineal prostate biopsy with coaxial method	coaxial prostate biopsy	The patients undergo transperineal biopsy with a coaxial Tru-Cut needle (18-gauge Core Biopsy Instrument with a 17-gauge Disposable Coaxial Needle).
transperineal prostate biopsy with noncoaxial method	noncoaxial prostate biopsy	The patients undergo transperineal biopsy with a noncoaxial 18-gauge needle.

Primary Outcome Measures

Name	Time	Method
complication ratio	within 48 hours after the procedure

Trial Locations

Locations (1)

Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences; 🇮🇷 Rasht, Guilan, Iran, Islamic Republic of