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INTERNATIONAL JOURNAL OF PRECISION ENGINEERING AND MANUFACTURING Vol. 15, No. 1, pp. 169-175 JANUARY 2014 / 169
© KSPE and Springer 2014
Digital Rectal Examination in a Simulated Environmentusing Sweeping Palpation and Mechanical Localization
Yeongjin Kim1, Bummo Ahn2, Youngjin Na1, Taeyoung Shin3, Koonho Rha3, and Jung Kim1,#
1 Department of Mechanical Engineering, KAIST, 291 Daehak-ro, Yuseong-gu, Daejeon, Korea, 305-7012 The Simulation Group, Center for Integration of Medicine and Innovative Technology, Department of Radiology, Harvard Medical School, Cambridge, USA
3 Department of Urology, Yonsei University College of Medicine, Urological Science Institute, Seoul, Korea# Corresponding Author / E-mail: [email protected], TEL: +82-42-350-3231, FAX: +82-42-350-5230
KEYWORDS: Prostate cancer, Mechanical diagnosis, Mechanical property map
Computerized palpation systems have been studied for the quantitative characterization of prostate properties. The aim of this study
was to evaluate the reliability of mechanical tumor localization maps by estimating correlation with pathological maps. A total of 120
indentations were performed on 10 specimens by using a sweeping palpation system in simulated environment conditions. Suspicious
tumor lesions from the mechanical localization were compared to those of the pathological maps. The concordance rate between the
mechanical localization maps and pathological maps was 81.7% (98/120). The positive predictive value (PPV) and the negative
predictive value (NPV) of the proposed localization system were 78.6% (59/75) and 86.7% (39/45), respectively. Based on these data,
the suspicious tumor lesions of mechanical localization maps were in close agreement with those from the pathological maps. The
findings suggest that the high compatibility and detection rate of prostate tumor could be enhanced if computerized palpation and
the conventional diagnosis are used synergistically. This study may contribute to technological progress in overcoming diagnostic
limitations, which include many complications from digital rectal examination (DRE) and transrectal ultrasound (TRUS) guided
needle biopsy.
Manuscript received: May 24, 2013 / Accepted: November 26, 2013
1. Introduction
Prostate cancer is the most common cancer in men over 50, and
more men will die due to prostate cancer than from any other cancer
except lung cancer. To detect prostate cancer, physicians typically have
used digital rectal examination (DRE), a serum prostate specific
antigen test (PSA test), and finally, transrectal ultrasound (TRUS)-
guided biopsy.1-5 However, a PSA test alone is not a reliable method for
detecting prostate cancer.6 It has been reported that the positive
predictive value (PPV) for DRE alone is as low as 28.0%,7 and even
in cases of men with abnormal PSA levels, the PPV of DRE is up to
33%8 The cancer detection rate of the biopsy is approximately 25%,9
and it has side effects after the biopsy, such as pain, post-biopsy
infection, hematuria, hematochezia, hematospermia, vasovagal reflex,
voiding difficulty and acute urinary retention.10 Fortunately, with the
combination of DRE, PSA, as well as family and personal history
tracking, many studies have shown that fewer men need to undergo the
biopsy to detect clinically prostate cancer (that is, the early detection
rate of prostate cancer can be enhanced if DRE, the PSA test, and the
history tracking are used synergistically).11-14 DRE has advantages such
as the prompt availability, cost effectiveness, and low risk. However,
compared to other tests, its results are not objective or quantitative
enough to constitute a primary test in this modern clinical environment
because of lack of quantitative analysis and property criteria, resulting
from a strong dependence on the surgeon’s skill and experience.14
Thus, it is possible to improve the detection rate of DRE through the
use of computerized palpation and quantitative analysis to provide
greater accuracy and safer diagnoses for patients.
Physicians usually depend on tactile sensation to guide manipulation
and exploration during open surgery.15 These tactile sensations can
provide the localization and assessment of tumors during open surgery.
Robot assisted minimally invasive surgery motivated by the success of
commercial surgical robots provides advantages over traditional open
surgery, including increased dexterity, precision, and control, but
eliminates the physicians’ tactile sensation.16 Because of the importance
of tactile sensation in localization and surgery, investigations have been
initiated for the use of computerized palpation devices in urology and
other related fields17-25 Computerized palpation is one of major interest
DOI: 10.1007/s12541-013-0321-6
170 / JANUARY 2014 INTERNATIONAL JOURNAL OF PRECISION ENGINEERING AND MANUFACTURING Vol. 15, No. 1
for medical technique that it could replace subjective palpation and
tactile sensation by acquisition of quantitative tactile feedback. The
palpation results and mechanical property characterization are a possible
solution that facilitates to obtain objective and quantitative information
for abnormal tissue localization during diagnosis and surgery.17-19 A
few researchers have developed computerized palpation systems to
discriminate the target tissues (hard tissue or tumor) from the normal
tissue.20-30 Among the several mechanical palpation techniques, early
indentation have been successfully applied to measure in-vitro tissue
behavior but do not provide a sufficient functionality for in-vivo
localization due to their limited stimulation patterns. Much time and
efforts on the user are required to obtain tissue information for a large
coverage area.6 In clinical palpation, the physicians provide more
complex patterns of finger motion on the tissue surface and combine
motions orthogonal to the surface of the rectum wall with motions
parallel to the surface. Such motions could be more effective by
enhancing the percepts of form,31,32 texture33 and location of tumors.
However, the experimental conditions in the human palpation are very
different from those in one dimensional indentation experiments.
Therefore, the indentation has limited applicability for abnormal tissue
localization. Moreover, for clinical applications, the palpation should
be coupled with image guidance techniques because the palpation tool
cannot reach the target organ without image guidance. Thus, we suggest
a novel sweeping palpation system that can be easily attached to ultra-
sound imaging systems. The sweeping palpation is applied in the
normal direction with a slanted probe followed by rotational motion at
a fixed point. This palpation method is similar to the finger motion
used during palpation by physicians in clinical practice.34 By using
ultrasound imaging system, physicians can obtain the suspected tumor
lesion. Then, our system can be utilized to more precisely focus on the
suspicious tissue area instantly for the accurate needle biopsy.
The property characterization methods suggested by the previous
studies were built on overly simplified assumptions, which limit the
validity of mechanical property characterization. Previous models did
not consider boundary conditions and surface geometry in local
mechanical stimulation experiments and do not include the local
property variance of prostate glands due to the multi-focal nodules of
prostate tumors. It is therefore necessary to develop local prostate
models that cover all of the regions of the prostate. Moreover, prostate
size and geometry vary by patient. For accurate property estimation, we
estimate the mechanical properties of the tissues based on local and
patient-specific biomechanical models while considering surface
geometries using three-dimensional surface reconstructions from
sequential scanning images. We have suggested an localization
procedure to determine the suspicious regions for each subject using
the experimental results. Finally, we have confirmed that the developed
system can distinguish cancerous tissues from normal tissues by
comparing the suspicious regions obtained from the proposed procedure
to pathological tumor maps.
2. Materials and Methods
2.1 Experimental setup
Through discussions with physicians on the required range and
space constraints of DRE motion, a set of preliminary requirements for
the palpation module was prepared. The probe tip should pass through
the small orifice (anus) when entering the body. The motion range of
the palpation module should be larger than 100 mm straight from the
entry site and should cover 40 mm (width) × 40 mm (height) in place
to reach the target (prostate). The system is designed to induce a
palpation to the target tissue and to measure the tissue behavior against
the palpation. The system dimension and operation range can be
determined using the comments of the physicians. The ultrasound-
guided palpation system consists of a three link system, an ultrasound
probe, and a palpation module. The three link system with two encoders
(E20s, Autonics) was developed to support the ultrasound probe and
track the probe motion by measuring the angle of yaw and pitch
direction. The ultrasound probe system (8808, BK Medical, USA) was
used to align the palpation module to the target regions of tissues. The
palpation module is composed of a C-500 sensor (Tactarray, USA) and
the attached frame with the ultrasound probe. The palpation module is
located on the opposite side of the ultrasound probe module. The
human prostate is suspended by the pubo-urethral ligaments and pubo-
prostatic ligaments. The dorsal midline fibrous raphe dorsally anchors
the prostate with Denonvilliers’ fascia, and the prostate is supported by
the pelvic bones.35 In addition, a layer of fat covers the prostate. These
anatomical features and in vivo experimental conditions should be
Fig. 1 (a) Ultrasound probe, palpation module, and palpation module
support; (b) Combination of the DRE simulator model and an artificial
support
INTERNATIONAL JOURNAL OF PRECISION ENGINEERING AND MANUFACTURING Vol. 15, No. 1 JANUARY 2014 / 171
taken into consideration to obtain more precise properties of the
prostate. Thus, for the simulated environmental condition, an artificial
support in the DRE simulator model (MK-2, Limbs and things, USA)
was developed by considering the pelvic bone and the ligaments as
shown in Fig. 1. The three dimensional morphology of the bone and
ligament around the prostate tissue was segmented by urologic experts.
Based on the obtained morphology, a three dimensional printer (rapid
prototype) was used to develop the artificial support.
2.2 Sweeping palpation experiments
All patients provided written informed consent, and the study was
approved by the Severance Hospital Institutional Review Board (IRB
No: 1-2011-0048). Prostate specimens were obtained from 10 patients
who had undergone radical prostatectomy at Severance Hospital, Yonsei
University, Seoul, Korea from October 2011 to March 2012. The mean
age of patients was 60.6±5.71 years (range 51-70 years), and the mean
value of PSA level was 15.1±13.5 ng/mL (range, 4.9-37.7 ng/mL). The
mean preoperative volume of the prostates was 26.4±7.7 mL (range,
18.3-39.4 mL). The pathologic cancer stage was T2a in 1 patient, T2c
in 3 patients, T3a in 4 patients, and T3b in 2 patients. The investigator
who conducted the experiments was blind to the clinical information.
The specimen is placed and fixed on the artificial support in the DRE
simulator. The US probe system is brought into contact with the
specimen through the DRE simulator model’s anus to align the target
regions and the US probe. When the US probe is rotated 180 degrees
along the x-axis (red line), the force sensor tip induces a 3 mm deep
sweeping palpation as shown in Fig. 2. The sweeping palpation consists
of a normal directional motion with a slanted probe and a rotational
motion at a fixed point. Using the sweeping palpation, the system can
access the rectal space, via the anus, which has a smaller diameter.34
The reaction forces were obtained with a data acquisition system. The
task sequence as outlined above is repeated at twelve regions to
identify suspect areas. The experiments were performed within 30
minutes after the extraction of the specimen in the operating room. For
each prostate specimen, the sweeping palpation experiments were
performed at 12 regions across the posterior surface as shown in Fig.
3(c). These 12 regions were referenced by those of double-sextant
needle biopsies, including the lateral apex (LA), lateral-mid (LM),
lateral base (LB), medial apex (MA), medial mid (MM), and medial
base (MB). A total of 120 indentations were performed on the 10
specimens.
2.3 Mechanical property characterization and localization
For accurate property characterization, laser scanning systems
(Pythagoras, Cylod, USA) were used to obtain the three dimensional
morphologies of the resected prostate tissues, as shown in Fig. 3. The
morphologies were converted to geometric finite element (FE) models
of the prostate tissues. The simulated model consisted of 112,710 nodes
with a total of 105,000 brick elements (C3D8). A no-slip condition was
assumed between the tissue and the artificial support. The normal and
tangential contact between the probe tip and the tissue was assumed to
be hard and frictionless. The elastic modulus and Poisson’s ratio were
used to represent mechanical properties of the prostate. The prostate
was assumed to be incompressible (v = 0.499). The FE simulations
were performed using the ABAQUS (SIMULIA, USA).36 The reaction
force values of the simulation were fitted to those of the experimental
results. The estimated elastic moduli were compared with the local
normal criteria to localize the prostate tumor. The steps for localizing
the tumor with the local normal criteria are shown in Fig. 4.37 Local
reaction forces are measured from the twelve region sweeping
experiments, and then local elastic moduli are estimated by the local
prostate model (Fig. 4(b)). The local normal criteria represent the sum
of the mean value and standard deviation (Fig. 4(a) and Table 1). The
Fig. 2 (a) Ultrasound probe, palpation module, and palpation module
support; (b) Combination of the DRE simulator model and an artificial
support
Fig. 3 (a) 3D geometric analysis of resected prostate tissue and 3D
reconstruction for FE analysis, (b) local FE models and (c) double
sextant sections
172 / JANUARY 2014 INTERNATIONAL JOURNAL OF PRECISION ENGINEERING AND MANUFACTURING Vol. 15, No. 1
localization step was performed by comparing the estimated local elastic
moduli and the normal property criteria (Fig. 4(c)). Then, we compared
the obtained localization results to the pathological results, which had
been confirmed by an uro-pathologist who was blinded to the conditions
of the study.
3. Results
The overall mechanical properties of 120 regions from 10 prostate
specimens were obtained using the experimental results and the FEM-
based mechanical property characterizations. Since the geometries and
contact conditions of the prostate tissue are not flat and smooth surface,
the force responses were not identical with ideal results (FE simulation
results). In Fig. 5(a), the normal property criteria were used for
comparison with the properties of the ten subjects. Fig. 5(a) represents
the optimized elastic modulus of the ten subjects by regions. Using the
Fig. 4 Steps to localize and differentiate abnormalities using the optimized elastic modulus database and case study results (a) Local normal tissue
criteria from the CCP model database (b) Local property estimation from the experimental results and homogenous model characterization (c)
Localization using the comparison of experimental results and local normal criteria
Table 1 The UE and the FRE for each subject (mean standard deviation). The UE was measured during 10 trials on each subject in the free metallic
environment
LB MB LM MM LA MA
Normal tissue 17.28±6.60 18.6±7.25 13.05±6.25 13.88±5.80 13.24±6.25 12.07±5.90
n 32 43 32 39 28 32
Fig. 5 (a) Local normal property criteria and local mechanical properties
of all subjects (b) Typical stress distributions for local property
estimation
Table 2 The UE and the FRE for each subject (mean standard deviation).
The UE was measured during 10 trials on each subject in the free
metallic environment
Subject number Mechanical analysis results Pathological results
A 4,8,12 4,8,11,12
B 1,2,3,4 1,2,3,4,6,7
C 1,2,3,4,7 1,2,3,4,6,7
D 1,2,4,5,6,7,8,11,12 1,2,3,4,5,6,7,8,11,12
E 1,2,3,4,5,6,7,8,9,12 1,2,3,4,5,6,7,8
F 1,2,3,4,6,7,8,12 1,2,3,4,6,7,8
G 1,4,5,8,9,10,11,12 1,4,5,8,12
H 1,2,3,4,5,9,10,11 1,2,3,4,5
I 1,2,3,4,5,6,7,8,10,11,12 1,2,3,4,5,6,7,10
J 1,2,4,5,7,8,9,11,12 1,2,3,4,7,11
INTERNATIONAL JOURNAL OF PRECISION ENGINEERING AND MANUFACTURING Vol. 15, No. 1 JANUARY 2014 / 173
localization steps, we can determine the suspicious regions for each
subject and compare them to the pathological results, as shown in Table
2. The mechanical localization was performed using statistical
significance (p-values < 0.01) between the normal property criteria and
the optimized properties of the ten subjects for each region. Table 2
shows the mechanical localization results and the pathological results
that had been confirmed by an uro-pathologist under blinded conditions.
The concordance rate between the localization results and the pathologic
results was 81.7 % (98/120). The sensitivity and specificity of the
proposed diagnostic system were 90.7% (59/65) and 70.9% (39/55),
respectively. While the positive predictive value (PPV) 78.6% (59/75),
negative predictive value (NPV) was 86.7% (39/45).
4. Discussion
In this paper, we proposed the normal property criteria and a
localization procedure to determine the suspicious regions for each
subject by using the local FE prostate model fitting with experimental
results. Then, we compared the suspicious regions from mechanical
localization with the pathological results. From this comparison, results
showed high sensitivity, specificity, NPVs, and PPVs. The developed
system could distinguish tumor regions more effectively compared to
the conventional DRE because of the following reasons. While the
layers of rectal wall, and Levator fascia, prostatic fascia, Denovilier’s
fascia and fat covers the prostate in in-vivo condition, these anatomical
features are not included in our simulated environment conditions. Our
palpation system has direct contact with resected prostate tissue while
the physician’s fingertip in DRE was interfered by the anatomical
features above the prostate. Gwilliam et al.16 and Salvazyan et al.38
reported the findings that computerized palpation is more effective at
detecting tumor than human finger and our results also supports the
findings. The developed system and proposed diagnostic procedure can
be used as a good screening and confirmation protocol for prostate
tumor. Physicians can obtain mechanical information on the target
tissues that can be used to designate the suspicious tissue regions of
patients more precisely than DRE.
Important issues are the experimental conditions related to prostate
geometry and the size of the probing tips. If the sample thickness is
comparable to the size of the tip, the hardness of the underlying substrate
may influence the apparent mechanical properties.39 In addition, prostate
size and geometry vary by patient. For a more accurate characterization,
the morphologies of the resected prostate tissue should be obtained for
modeling of the prostate. In this study, we used the laser scanner for
geometric scanning and reconstructed the prostate model for patient-
specific property characterization. As a result, our characterization
results showed high sensitivity, specificity, NPV, and PPV. Despite these
improvements, there still remain limitations; the palpation at apex regions
shows lower PPV compared to that of the mid and base because
thickness of apex regions is relatively thinner than that of other regions.
While tissue properties were obtained in both the peripheral zones with
good correlation to pathological results, the deepest transition zone may
not be correctly assessed by using our system. Gwillium et al. shows
that large tumor closer to the surface are easiest to detect while small
tumor embedded deepest are most difficult to detect.16 Bloom et al.
shows that detectability of tumor are most related with tumor depth
from the exposed surface of the tissue among the stimulus parameters
including tumor size, depth, hardness, and mobility.40 In addition, the
prostate hyperplasia, prostatic calcification, cysts and inflammatory
granuloma might have induced changes in the elasticity of the prostate
in this study.41
The choice of diagnostic criteria is also dependent on how the data
in both elastography and DRE are used.42 One of the most challenging
issues in mechanical diagnosis is the choice of diagnostic criteria. Every
physician has different and subjective standards in regard to DRE
findings; these differences lead to miscommunication in the exchange
of information about disease entities among physicians. In this study,
we proposed normal property criteria (sum of the mean and standard
deviation) that determine the suspicious regions for each subject and
compared them to the pathological results of the cancer location. There
are additional values for diagnostic criteria, such as the maximum of
normal properties and the highest quartile of normal properties. To
compare the results, statistical analysis was carried out to obtain a PPV
for each criterion. The PPVs of the criteria were 85.1% (40/47) and
68.5% (61/89). The sensitivities of the criteria were 61.5% (40/65) and
93.8% (61/65). We used the sum of the mean values and standard
deviations as the diagnostic standard in this study.
5. Conclusion
In this paper, we developed a palpation system that can be used to
overcome the limitations of the conventional DRE method. To
demonstrate its safety and potential application as a clinically practical
tool for prostate tumor detection, our systems could be easily attached
to an ultrasound probe or elastography system. Through ultrasound
imaging, physicians can visualize the suspected lesion. Then, our system
can be utilized to instantly and more precisely focus on the suspected
tissue area. We proposed criteria and a localization procedure to
determine the suspicious regions for each subject using the FE prostate
model fitting with experimental results. Then, we compared the suspicious
regions from mechanical analysis with the pathological results.
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