Comparison of the complications of traditional 12 cores transrectal prostate biopsy with image fusion guided transperineal prostate biopsy
Huang et al. BMC Urology
Comparison of the complications of traditional 12 cores transrectal prostate biopsy with image fusion guided transperineal prostate biopsy
Haifeng Huang 1
Wei Wang 1
Tingsheng Lin 1
Qing Zhang 1
Xiaozhi Zhao 1
Huibo Lian 1
Hongqian Guo 0 1
0 Institute of Urology, Nanjing University , Nanjing 210008 , China
1 Department of Urology, Affiliated Drum Tower Hospital, Medical School of Nanjing University , Nanjing 210008 , China
Background: To compare the complications of traditional transrectal (TR) prostate biopsy and image fusion guided transperineal (TP) prostate biopsy in our center. Methods: Two hundred and fourty-two patients who underwent prostate biopsy from August 2014 to January 2015were reviewed. Among them, 144 patients underwent systematic 12-core transrectal ultrasonography (TRUS) guided prostate biopsy (TR approach) while 98 patients underwent free-hand transperineal targeted biopsy with TRUS and multi-parameter magnetic resonance imaging (mpMRI) fusion images (TP approach). The complications of the two groups were presented and a simple statistical analysis was performed to compare the two groups. Results: The cohort of our study include242 patients, including 144 patients underwent TR biopsies while 98 patients underwentTP biopsies. There was no significant difference of major complications, including sepsis, bleeding and other complication requiring admissionbetween the two groups (P > 0.05). The incidence rate of infection and rectal bleeding in TR was much higher than TP (p < 0.05), but the incidence rate of perineal swelling in TP was much higher than TR (p < 0.05). There were no significant differences of minor complications including hematuria, lower urinary tract symptoms (LUTS), dysuria, and acuteurinary retention between the two groups (p > 0.05). Conclusion: The present study supports the safety of both techniques. Free-handTP targeted prostate biopsy with real-time fusion imaging of mpMRI and TR ultrasound is a good approach for prostate biopsy.
Prostate biopsy; Prostate cancer; Fusion image; Magnetic resonance imaging; Complications
Biopsies of the prostate have been used to diagnose
prostate cancer since the beginning of the last century
. The field of prostate diagnostics, especially biopsy
techniques develops rapidly . Transrectal
ultrasonography (TRUS) guided prostate biopsy, which isperformed
with a core biopsy needle passing through the rectum,
was first applied for the biopsy of prostate in 1968 .
Since the introduction of the systematic 12-core
transrectal prostate biopsy guided by TRUS, it has become
awidely accepted, routinely performed technique for
prostate cancer detection . The transperineal prostate
biopsy, which is performed with the core biopsy needle
passing through the skin of the perineum, is far less
common compared with transrectal biopsy .
Several studies have demonstrated that the transrectal
technique is a faster and convenient approach for
prostate biopsy. Though the minor complications rate of
hematuria, rectal bleeding, hematospermia, vasovagal
episodes, infection was reported to be similar in these
two techniques , transrectal prostate biopsy had more
major complicationse.g. sepsis, bleeding or other
complications requiring admission compared with the
transperineal biopsy [7, 8]. More importantly, an increasing risk
of septic shock was reported in the transrectal biopsy,
which might be life-threatening [9, 10].
© The Author(s). 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
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Recently, transperineal prostate biopsy has been
becoming an increasingly popular approach for accurate
diagnosis and risk stratification of prostate cancer .
MRI/US-fusion-guided biopsyis a potential approach to
offer improved diagnostic information over systematic
12-core transrectal prostate biopsy guided by TURS
alone [12, 13]. We have previously described free-hand
transperineal targeted biopsy guided by TRUS and
mpMRI fusion images . The targeted biopsy is a
precise, faster and more accessible technique for prostate
biopsy compared to systematic biopsy. In the present
study, we reported the complications of transperineal
targeted biopsy guided by TRUS-mpMRI fusion images
and traditional 12 cores systematic transrectal biopsy
guided by TURS in our center.
The study protocol was approved by the local institutional
review board at Nanjing University (NJU201500987), and
informed written consent was received from patients,
including acquiring essential medical images for publication.
Research was carried out in compliance with the Helsinki
The present study was performed by reviewing a total of
262 patients who underwent prostate biopsy from August
2014 to January 2015. At the time of analysis, the database
contained 262 patients of whom 20 were excluded
because of <10 cores taken in systematic biopsies. Thus, 242
patients were available for analysis. These patients with
PSA level greater than 4.0 ng/mL underwent mpMRI
prospectively. All these patients were assessed with prostate
mpMRI in the radiology department of our hospital, and
98 patients had at least one suspicious areas in mpMRI
images who underwent free-hand transperineal targeted
biopsy with TRUS and multi-parameter magnetic
resonance imaging (mpMRI) fusion images (TP approach). The
Table 1 Characteristics of patients
BMI, kg/m2 (range)
PSA, ng/ml (range)
Prostate volume, ml (range)
Suspicious DRE findings (rate)
biopsy time, min (range)
biopsy number (range)
Gleason score (range)
Follow up, months (range)
other 144 patients underwent systematic 12-core
Transrectal Ultrasonography (TRUS) guided prostate biopsy
(TR approach). No patients had any previous history of
prostate biopsy. All patients had given informed consent.
Patient demographics including age, digital rectal
examination (DRE) findings (recorded as benign, suspicious,
malignant or unknown), Body Mass Index (BMI, kg/m2),
prostate volume, serum total prostate specific antigen
(PSA), biopsy technique (transperineal or transrectal),
total number of cores taken, number of cores positive for
prostate adenocarcinoma from histology, Gleason grade
and score, positive biopsies, complications (The major
complications included sepsis and severe hematuria, the
minor complications included minor hematuria, LUTS
(lower urinary tract symptoms), dysuria, acute urinary
retention, infection, rectal bleeding, perineal swelling) and
treatments of the study cohort are shown in Table 1. In
our study, rectal bleeding was defined as the passage of
bright red blood rectally > 12 h after biopsy, or any bleed
requiring active management irrespective of the time of
occurrence. Major hameaturia was defined as obvious
gross hematuria with or without blood clot, minor
hameaturia was defined as no obvious gross hematuria and was
confirmed microscopic hematuria.
All prostate biopsies were performed by an experienced
urologist. (W. W). We used the cefuroxime sodium (1.5g,
intravenous drip) for anti-infective prophylactic therapy.
Systematic 12-core prostate biopsy were performed under
transrectal ultrasound guidance, a standard of twelve
cores was taken using TR approach. TR approach were
performed with the patient in the left decubitus position,
using an 18-G automatic biopsy gun with a specimen size
of 22 mm (Bard Magnum; Bard Medical, Covington, GA,
USA), 20 ml of Lidocaine gel was introduced intra-rectally
15 min before the procedure, the sextant biopsies were
taken laterally in the prostate from the base, midline and
apex, 3 cores were taken from each side from the far
lateral areas of the prostate at the base, midline and
near the apex. TP approach was performed according
65.61 ± 11.21 (51~86)
27.81 ± 4.86 (23.5~34.7)
11.23 ± 6.82 (6.3~46.7)
32.62 ± 9.11 (20.5~67.8)
11.55 ± 6.71 (10~26)
6.89 ± 0.75 (6~9)
7.51 ± 4.26 (1~12)
63.40 ± 9.81 (50~77)
28.60 ± 5.17 (22.4~35.1)
9.61 ± 7.94 (4.6~36.6)
34.21 ± 6.42 (23.5~59.8)
16.61 ± 7.82 (12~39)
to our previous study. Multi-parametric MRI
examination and TRUS-mpMRI image fusion were shown in
Additional file 1. Biopsy protocol: The biopsy started
with target biopsy to the center of cancer-suspicious
lesions without the guide of template using the free-hand
transperineal technique, and then, standard 12-core
stand biopsy (blinded to the MRI target lesions) was
carried out in all patients. Lesions suspicious of cancer
identified on MRI were semi automatically displayed on
the real-time TRUS image . All target lesions were
sampled once in both axial and sagittal planes, with at
least two core biopsies per target. An 18-G automatic
biopsy gun with a specimen size of 22 mm (Bard Magnum;
Bard Medical, Covington, GA, USA) was used to take
biopsy cores. All patients underwent general anesthesia
using a larynx mask during the biopsy procedure.
Data are presented as the Mean ± SD. Statistical analysis
involved use of SPSS 17.0 (SPSS Inc, Chicago, IL).
Between-group comparisons involved t test and
chisquare test. P<0.05 was considered statistically significant.
Patients demographics are shown in Table 1. The
patients were divided into two groups based on the
different prostate biopsy techniques. A total of 242 patients
were included in the study. Among them, 144 men
underwent transrectal biopsies while 98 men underwent
transperineal biopsies. The mean age of the TR biopsies
and TP biopsies was 65.61 ± 11.2 years (range 51–86
years) and 63.40 ± 9.81 years (range 50–77
years)respectively. The mean BMI of TR and TP was 27.81 ± 4.86
kg/m2 (range 23.5 ~ 34.7 kg/m2) and 28.60 ± 5.17 kg/m2
(range 22.4 ~ 35.1 kg/m ) respectively. The mean
preoperative PSA value of TR and TP was 11.23 ± 6.82 ng/
mL (range 6.3 ~ 46.7 ng/mL) and 9.61 ± 7.94 ng/mL
(range 4.6 ~ 36.6 ng/mL) respectively. The mean
preoperative prostate volume of TR and TP, calculated
using the ellipsoid formula, was 32.62 ± 9.11 mL (range
20.5 ~ 67.8 mL) and 34.21 ± 6.42 mL (range 23.5 ~ 59.8
mL), respectively. Nine patients in TR (6.3%) had a
recognized palpable nodule in the prostate based on digital
rectal examination (DRE), and six patients in TP (6.1%)
had suspicious DRE findings. The mean biopsy time of
TR was 11.55 ± 6.71 min (range 10–26 min). The mean
biopsy time of TP, including the MRI-TRUS fusion time
and needle puncture time without anesthesia, was 16.61 ±
7.82 min (range 12–39 min). The biopsy time of TR was
shorter than TP (p < 0.001). The mean Gleason score of
TR was 6.89 ± 0.75 (range 6 ~ 9) whilethe mean Gleason
score of TP was 7.10 ± 0.89 (range 6 ~ 9). The mean
follow-up of TR was 7.51 ± 4.26 months (range 1 ~ 12
months) while the mean follow-up of TP was 8.12 ± 5.15
months (range 1.5 ~ 13 months). There were no
significant differences between TR and TP in age, BMI, PSA,
prostate volume, suspicious DRE findings, Gleason score,
during the follow-up period (p > 0.05).
The comparative pathological results of prostate
biopsies in TR and TP are shown in Table 2. The TR and TP
detected prostate cancer (PCa) in 57 (39.6%) and 51
(52.0%) patients, respectively. The TR detected
Highgrade PIN, Low-grade prostatic intraepithelial neoplasia
(PIN) in 10 (6.9%) and 7 (4.9%) patients, respectively.
The TP detected High-grade PIN, Low-grade PIN in 5
(5.1%) and 6 (6.1%) patients, respectively. The TR and
TP detected benign prostate hyperplasia (BPH) in 59
(40.9%) and 32 (32.7%) patients, respectively. The TR
and TP detected chronic prostatit is in 11 (7.6%) and 4
(4.1%) patients, respectively.
Comparison of the positive (detected PCa) and
negative (undetected PCa) results of TR and TP according to
PSA classification is shown in Table 3. In patients who’s
PSA level lower than 10ng/ml, The TR and TP detected
PCain 8 and 4patients, respectively. (p = 0.401). In patients
who’sPSA between 10 to 20ng/ml, The TR and TP
detected PCain13 patients, respectively (p = 0.895). In
patients who’sPSA higher than 20ng/ml, The TR and TP
detected PCain36 and 40 patients, respectively (p = 0.029).
The PCa detection rate of TP was much higher than TR
in patients who’sPSA higher than 20ng/ml (p < 0.05).
Complications rates of the two groups were recorded
and the results are presented in Table 4. The major
complications included sepsis and severe hematuria. The
minor complications included minor hematuria, lower
urinary tract symptoms (LUTS), dysuria, acute urinary
retention, infection, rectal bleeding, perineal swelling. In
the TR group, one patient (0.7%) had sepsis and treated
with admitted intravenous (IV) antibiotics. Two patients
(1.38%) had severe hematuria. In the TP group, no
patient had major complications. However, there was no
significant difference between two groups of major
Table 2 Comparison of the pathological results TR biopsy and TP biopsy
PIN prostate intraepithelial neoplasm
complications (P > 0.05). There were significant differences
between the two groups of minor complications in
infection, rectal bleeding, and perineal swelling. As shown in
Table 4,there were 16 patients in TR (11.11%) and 3
patients in TP (3.06%) with infection.2 patients in TR (1.4%)
and no patients in TP (0%) had rectal bleeding. 3 patients
in TR (2.08%) and 10 patients in TP (10.2%) had perineal
swelling. The rate of infection and rectal bleeding in TR
were much higher than TP (p < 0.05) However, the rate of
perineal swelling in TP was much higher than TR (p <
0.05). There were no significant differences of minor
complications including minor hematuria, LUTS dysuria, acute
urinary retention between thetwo groups (p > 0.05), in spite
of more biopsy cores in TP biopsy.
Total complications in each patient of TR and TP
were shown in Table 5. There were 18 patients (12.5%)
without any complication after biopsy in TR and 29
patients (29.59%) without any complication after biopsy in
TP. There were more patients without any complications
in TP group than that in TR (p < 0.001). 43 patients
(29.86%) with one complication were detected in TR
and 41 patients (41.83%) in TP. 45 patients (31.25%)
with two complications after biopsy were found in TR
group and 21 patients (21.42%) in TP.34 patients
(23.61%) were found with more than three
complications after biopsy in TR and 7 patients (7.14%) in TP.
The rate of multiple complications after biopsy in TR
were much higher than TP (p < 0.001).
Table 5 Total complications in each patient of TR and TP
The present results showed that cancer detection rate of
TP group were higher than TR group (Table 2). This
might be due tothat the TP group had at least one
suspicious area in mp MRI images and included at least one
targeted biopsy, but the TP group had notargeted biopsy.
Complication rate of prostate biopsies varies widely in
medical literature. Several studies reveal major
complications (sepsis, bleeding or other complication requiring
admission) rates of around 1–2% in transrectal prostate
biopsy, with the following rates of minor complications:
hematuria 10–84%; rectal bleeding 1.3–45%;
hematospermia 1.1–93%; vasovagal episodes 0–5%; infective
complications 0–6.3% [7, 15]. Studies also reveal similar
wide-ranging rates of minor complications in
transperineal biopsies. Recently, a systematic review showed that
the rate of sepsis after TRUS biopsy is as high as 5%,
and appears to be rising with increasing rates of
multiresistant bacteria found in rectal flora. However, the rate
of sepsis from published series of TP biopsy approached
zero , andour results was consistent with the
conclusions from the literature.
In our study, the major complications rate following
TR was 2%, whereas no patient had a major
complication following TP (Table 4). However, there was no
significant difference between the rate of major
complications in the two groups (P > 0.05). Of note, there
was one case of sepsis in the TR approach, and cured
by admitted intravenous drip antibiotics. Visible
hematuria following prostate biopsy is common, with
reported rates of 10–84% . Bleeding post procedure is
usually self-limiting and rarely life threatening. Two
patients had severe hematuria and cured by continuous
bladder irrigation. Mortality after prostate biopsy is
extremely rare, and most reported deaths are the result
of septic shock. In fact, there was no patient died after
prostate biopsy in the present study.
Minor complication rates in both techniques were
comparable. Infection is a well-established risk of
prostate biopsy. Various strategies to reduce infectious
complications have been explored, as were recently reviewed
. Recently, several studies have shifted from the
transrectal to the transperineal technique with anecdotal
reports of very low rates of sepsis, even without the use of
prophylactic antibiotics [10, 16]. In this study, we also
found that the rate of infection in TR was significantly
Acute urinary retention
higher than TP (p < 0.05). The rate of infection and
rectal bleeding in TR were much higher than TP (p < 0.05),
while the rate of perineal swelling in TP was much
higher than TR (p < 0.05). This might be due to the
different approaches since more biopsy cores were taken in
TP procedure. Bleeding is the most frequently reported
complication after biopsy, but it is usually minor and
resolves spontaneously. The present study was unable to
prove any significant difference of minor complications
including minor hematuria, LUTS, dysuria, acute urinary
retention between the two groups (p > 0.05).
The TR approach is a much easier procedure and can
prevent patients’ discomfort by using only local anesthesia.
This changed after several reports of fatalities following
septic complications of transrectal biopsy . Image
fusion guided TP biopsy is increasingly popular as a mean
for accurate diagnosis and risk stratification [11, 18]. An
increasing number of studies have showed that MRI/US
image-fusion guided TP is an effective and accurate
method for prostate cancer diagnosis. Our study also
showed a higher prevalence of MRI/US image-fusion
guided TP proven cancers in suspicious areas, which can
result in better prostate cancer characterization via precise
localization, prediction of Gleason grade, and more
accurate cancer core length. Moreover, the incidence rate of
infection and rectal bleeding after biopsy in TP was much
less than TR.
There were some limitations in the present study. The
first is the retrospective study design was absence of
randomization. Second, there was inadequate sample
size in this study. Third, the procedure of TR with local
anesthesia was simplicity, but the procedure of TP with
general anesthesia was complexity. It is unknown whether
this difference has clinical significance, and how it affects
the complication rates. Further prospective multi-center
randomized controlled trials will be conducted.
The present study supports the safety of both
transrectal prostate biopsy and free-hand transperineal
targeted prostate biopsy with real-time fusion imaging of
mpMRI/US in the diagnosis of prostate cancer.
Transperineal prostate biopsy is safe with no cases of sepsis
recorded, and the rate of infection and rectal bleeding in
TP is much lower than TR, in spite of more biopsy cores
in TP biopsy. This suggests that free-hand transperineal
targeted prostate biopsy with real-time fusion imaging of
mpMRI/US can be a good approach for prostate biopsy.
DRE: Digital rectal examination; mpMRI: Multi-parameter magnetic resonance
imaging; TP: Transperineal; TR: Transrectal; TRUS: Transrectal Ultrasonography
This study was supported by a grant from the National Natural Science
Foundation of China (81302542, 81371207, and 81171047), China
Postdoctoral Science Foundation (2014M551562), and Fundamental
Research Funds for theCentral Universities (20620140532).
Availability of data and materials
The datasets supporting the conclusions of this article are available in the
Nanjing drum tower hospital Medical Records Room data base (Nanjing,
Jiangsu, China) repository.
All authors made substantial contributions to the conception, design, analysis
and interpretation of the data; HH drafted the first draft of the manuscript and
WW provided critical revision; all authors give final approval for the manuscript
and agree to be accountable for all aspects of the work herein.
The authors declare that they have no competing interests
Ethics and consent to participate
Informed consent was obtained for all participants and studies were approved
by the Institutional Review Board at Nanjing drum tower hospital.
1. Denmeade SR , Isaacs JT. A history of prostate cancer treatment . Nat Rev Cancer . 2002 ; 2 : 389 - 96 .
2. Yacoub JH , Verma S , Moulton JS , Eggener S , Oto A. Imaging-guided prostate biopsy: conventional and emerging techniques . Radiographics . 2012 ; 32 : 819 - 37 .
3. Lee F , Torp-Pedersen S , Siders D , Littrup P , McLeary R. Transrectal ultrasound in the diagnosis and staging of prostatic carcinoma . Radiology . 1989 ; 170 : 609 - 15 .
4. Hara R , et al. Optimal approach for prostate cancer detection as initial biopsy: prospective randomized study comparing transperineal versus transrectal systematic 12-core biopsy . Urology . 2008 ; 71 : 191 - 5 .
5. Moran BJ , Braccioforte MH . Stereotactic transperineal prostate biopsy . Urology . 2009 ; 73 : 386 - 8 .
6. Bittner N , Merrick GS , Butler WM , Bennett A , Galbreath RW . Incidence and pathological features of prostate cancer detected on transperineal template guided mapping biopsy after negative transrectal ultrasound guided biopsy . J Urol . 2013 ; 190 : 509 - 14 .
7. Loeb S , et al. Systematic review of complications of prostate biopsy . Eur Urol . 2013 ; 64 : 876 - 92 .
8. Selvanayagam A , Perera M , Roberts MJ , Pretorius CF . Perforated Rectal Diverticulum following Prostate Biopsy Resulting in Peri-Rectal Abscess and Sepsis . Surg Infect Case Rep . 2016 ; 1 : 2 - 3 .
9. Williamson , D.A. , et al. Infectious complications following transrectal ultrasoundguided prostate biopsy: new challenges in the era of multidrug-resistant Escherichia coli . Clinical infectious diseases , cit193 ( 2013 ).
10. Grummet JP , et al. Sepsis and 'superbugs': should we favour the transperineal over the transrectal approach for prostate biopsy ? BJU Int . 2014 ; 114 : 384 - 8 .
11. Scott S , Samaratunga H , Chabert C , Breckenridge M , Gianduzzo T. Is transperineal prostate biopsy more accurate than transrectal biopsy in determining final Gleason score and clinical risk category? A comparative analysis . BJU international . 2015 ; 116 : 26 - 30 .
12. Siddiqui MM , et al. Magnetic resonance imaging/ultrasound-fusion biopsy significantly upgrades prostate cancer versus systematic 12-core transrectal ultrasound biopsy . Eur Urol . 2013 ; 64 : 713 - 9 .
13. Rastinehad AR , Durand M. A comparison of magnetic resonance imaging and ultrasonography (MRI/US)‐fusion guided prostate biopsy devices: too many uncontrolled variables . BJU Int . 2016 ; 117 : 548 - 9 .
14. Zhang Q , et al. Free-hand transperineal targeted prostate biopsy with realtime fusion imaging of multiparametric magnetic resonance imaging and transrectal ultrasound: single-center experience in China . Int Urol Nephrol . 2015 ; 47 : 727 - 33 .
15. Patel U , et al. Infection after transrectal ultrasonography‐guided prostate biopsy: increased relative risks after recent international travel or antibiotic use . BJU Int . 2012 ; 109 : 1781 - 5 .
16. Zhou , Y. , Yan , W. & Li , H. Re : Eduard Baco, Erik Rud , Lars Magne Eri , et al. A Randomized Controlled Trial to Assess and Compare the Outcomes of Twocore Prostate Biopsy Guided by Fused Magnetic Resonance and Transrectal Ultrasound Images and Traditional 12-core Systematic Biopsy . Eur Urol 2016 ; 69 : 149 - 56 . European urology ( 2016 ).
17. Ogino , H. , et al. Transperineal Approach Versus Transrectal Approach for Fiducial Marker Placement in Proton Beam Therapy of Prostate Cancer: A Prospective Comparison . International Journal of Radiation Oncology Biology Physics 90 , S405 ( 2014 ).
18. Dowrick , A.S. , Wootten , A.C. , Howard , N. , Peters , J.S. & Murphy , D.G. A prospective study of the short‐term quality of life outcomes of patients undergoing transperineal prostate biopsy . BJU international ( 2016 ).