An interventional study of coaxial prostate biopsy and noncoaxial prostate biopsy in Biopsy, Prostate and Complication, sponsored by Modarres Hospital. Completed at 1 site in Iran, Islamic Republic of. Open to male participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-04-29.
Sponsored by Modarres Hospital · Not applicable and Interventional
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.
Modarres Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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
The patients undergo transperineal biopsy with a noncoaxial 18-gauge needle.
Device: noncoaxial 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).
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)
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)
complication ratio
Time frame: within 48 hours after the procedure
Plan to share: No
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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