Prostate Core Needle Biopsy

NCT02756975 | Completed

• 1 other identifier: Prostate Core Needle Biopsy
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Biopsy; Prostate; Complication

Outcome Measures

Primary Outcomes (1)

• complication ratio

  within 48 hours after the procedure

Study Arms (2)

transperineal prostate biopsy with coaxial method

EXPERIMENTAL

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

Device: coaxial prostate biopsy

transperineal prostate biopsy with noncoaxial method

EXPERIMENTAL

The patients undergo transperineal biopsy with a noncoaxial 18-gauge needle.

Device: noncoaxial prostate biopsy

Interventions

coaxial prostate biopsy DEVICE

In this method, a larger introducing needle is needed for the puncture. The introducing needle is placed over the perineum. The biopsy needle is inserted throughout the introducing needle.Then, the direction of the biopsy is changed by tilting the coaxial needle. The investigator needs to puncture the prostate capsule only once for sampling at each each side of the prostate (right and left sides).

Also known as: coaxial Tru-Cut needle (18-gauge Bard Max-Core Disposable Core Biopsy Instrument, 17-gauge Bard TruGuide Disposable Coaxial Needle; C. R. Bard, Tempe, USA)

transperineal prostate biopsy with coaxial method

noncoaxial prostate biopsy DEVICE

In this method, there is no introducing needle. Biopsy needle is inserted repeatedly for each tissue sampling (at least fourteen times). A smaller biopsy needle is used for the puncture in this method. The main disadvantage of the coaxial technique is that a larger introducing needle is needed for the puncture (12). On the other whand, the advantage of noncoaxial method is that the needle is within the prostate for only a few seconds to document needle position with ultrasonography before firing

Also known as: noncoaxial 18-gauge needle (Bard Max-Core Disposable Core Biopsy Instrument; C. R. Bard, Tempe, USA)

transperineal prostate biopsy with noncoaxial method

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Modarres Hospital: lead

Study Sites (1)

Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences

Rasht, Gilan Province, Iran

Location

Related Publications (2)

• Novella G, Ficarra V, Galfano A, Ballario R, Novara G, Cavalleri S, Artibani W. Pain assessment after original transperineal prostate biopsy using a coaxial needle. Urology. 2003 Oct;62(4):689-92. doi: 10.1016/s0090-4295(03)00483-7.

  PMID: 14550444 RESULT

• Chang DT, Challacombe B, Lawrentschuk N. Transperineal biopsy of the prostate--is this the future? Nat Rev Urol. 2013 Dec;10(12):690-702. doi: 10.1038/nrurol.2013.195. Epub 2013 Sep 24.

  PMID: 24061531 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 29, 2016
• Study Start: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)