Prostate Core Needle Biopsy

Complication Clinical Trial

— Prostate  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756975
• Other study ID #: Prostate Core Needle Biopsy
• Status: Completed
• Phase: N/A
• First received: April 26, 2016
• Last updated: April 27, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Modarres Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Biopsy
• Complication
• Prostate

Intervention

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).
• 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences	Rasht	Guilan

Sponsors (1)

Lead Sponsor	Collaborator
Modarres Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complication ratio		within 48 hours after the procedure	No