Prostate Core Needle Biopsy

Sponsor

Modarres Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02756975

Collaborator

(none)

240

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Biopsy Prostate Complication	Device: coaxial prostate biopsy Device: noncoaxial prostate biopsy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Feb 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: transperineal prostate biopsy with coaxial method 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 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). Other Names: 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)
Experimental: transperineal prostate biopsy with noncoaxial method The patients undergo transperineal biopsy with a noncoaxial 18-gauge needle.	Device: noncoaxial prostate biopsy 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 Other Names: noncoaxial 18-gauge needle (Bard Max-Core Disposable Core Biopsy Instrument; C. R. Bard, Tempe, USA)

Arm

Intervention/Treatment

Experimental: transperineal prostate biopsy with coaxial method

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

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).

Other Names:

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)

Experimental: transperineal prostate biopsy with noncoaxial method

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

Device: noncoaxial prostate biopsy

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

Other Names:

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

Outcome Measures

Primary Outcome Measures

complication ratio [within 48 hours after the procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences	Rasht	Guilan	Iran, Islamic Republic of

Sponsors and Collaborators

Modarres Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Modarres Hospital

ClinicalTrials.gov Identifier:

NCT02756975

Other Study ID Numbers:

Prostate Core Needle Biopsy

First Posted:

Apr 29, 2016

Last Update Posted:

Apr 29, 2016

Last Verified:

Apr 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Study Results

No Results Posted as of Apr 29, 2016