Prostate Core Needle Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Biopsy Prostate Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type EXPERIMENTAL

coaxial prostate biopsy

Intervention Type 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).

transperineal prostate biopsy with noncoaxial method

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

Group Type EXPERIMENTAL

noncoaxial prostate biopsy

Intervention Type 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

Interventions

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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).

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Rasht, Gilan Province, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type RESULT

PMID: 14550444 (View on PubMed)

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.

Reference Type RESULT

PMID: 24061531 (View on PubMed)

Other Identifiers

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