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OpenTrials
Completed

NCT Number: NCT02756975

Prostate Core Needle Biopsy

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.

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Key information

Conditions

Biopsy Complication Prostate

Age range

20 year–90 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

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

Rasht, Gilan Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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)

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

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

Primary outcomes

  1. complication ratio

    Time frame: within 48 hours after the procedure

Sponsors and collaborators

Lead sponsor

Modarres Hospital

Other

Registry information

Acronym: Prostate

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2016
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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