Prostate Core Needle Biopsy

M

Modarres Hospital

Status

Completed

Conditions

Complication
Prostate
Biopsy

Treatments

Device: noncoaxial prostate biopsy
Device: coaxial prostate biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT02756975
Prostate Core Needle Biopsy

Details and patient eligibility

About

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.

Enrollment

240 patients

Sex

Male

Ages

20 to 90 years old

Volunteers

No 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

Trial design

240 participants in 2 patient groups

transperineal prostate biopsy with coaxial method
Experimental group
Description:
The patients undergo transperineal biopsy with a coaxial Tru-Cut needle (18-gauge Core Biopsy Instrument with a 17-gauge Disposable Coaxial Needle).
Treatment:
Device: coaxial prostate biopsy
transperineal prostate biopsy with noncoaxial method
Experimental group
Description:
The patients undergo transperineal biopsy with a noncoaxial 18-gauge needle.
Treatment:
Device: noncoaxial prostate biopsy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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