Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy
The preservation of the neurovascular bundle (NVB) including cavernous nerves during radical
prostatectomy improves the postoperative recovery of sexual potency. At present, the
location of NVB is determined by the surgeon's visual estimation. However, NVB is difficult
to visualize with simple visual magnification of the surgical field with surgical loupes or
laparoscopic lenses due to the periprostatic connective tissue and intraoperative
hemorrhage. One approach to better estimate the location of the NVB is to identify a
macroscopic landmark to more clearly direct the surgeon to the location of the NVB. The
accompanying arteries and veins in the NVB, which are visible with Doppler ultrasound, can
serve as a macroscopic landmark to localize the microscopic cavernous nerves in the NVB.
Therefore, the use of TRUS imaging during radical prostatectomy can potentially improve the
visualization of the NVB and subsequently improve postoperative recovery of potency in men.
In addition, the 3-D shape of the prostate gland can potentially be clearly and accurately
delineated in ultrasounds imaging, providing direct guidance of landmarks to the surgeon.
Recently, intraoperative TRUS imaging has been used to visualize the prostate gland and NVB
during laparoscopic radical prostatectomy (LRP). The investigators reported that the
intraoperative use of TRUS was helpful in imaging the location and local extent of
hypoechoic area(s), providing real-time guidance for the surgeon during NVB release and
apical dissection of the prostate, and monitoring a calibrated, lobe-specific, wider
dissection around a cancer nodule with suspected extracapsular extension (ECE). With the
enhanced visualization of the surgical field by TRUS imaging, they reported significant
improvement in NVB preservation and a decreasing rate of positive surgical margin, which is
a surrogate for the technical quality of the surgery. However, several aspects related most
likely to technology limitations can further be improved. For example, the TRUS probe was
manipulated by a human assistant during LRP, compromising image stability especially with
Doppler imaging, discarding the pose of the images, and performing navigation based on the
recommendations of the assistant rather than using an actual navigation software. Moreover,
their application of TRUS can be used in the non-robotic LRP only, because the daVinci®
robot used in RALP occupies the place of a human assistant at the end of the operative
table. Finally, there was no objective measure to quantify the performance of the
Regardless of the study's shortcomings, the authors reported that their positive surgical
margin rates decreased precipitously since their use of the TRUS guidance, demonstrating
potential benefit of the TRUS-based guidance during surgery. Since their study, the use of
intraoperative TRUS guidance during prostate surgery has not gained wide acceptance, and
was, in fact, criticized because it requires an additional personnel with an expertise in
TRUS. Alternatively, we propose to use the TRUS Robot, a robotic arm to hold and manipulate
the TRUS probe remotely, allowing the surgeon to manipulate the TRUS probe without the need
for a human assistant during RALP. We also propose to use 3-D TRUS navigation with the
images obtained by the TRUS.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Accuracy of TRUS Robot and 3-D TRUS navigation software.
To assess whether NVB localization is accurate using the TRUS Robot and 3-D TRUS navigation software during T-RALP & can accurately locate and quantify the distance between anatomical landmarks.
Measurements will be recorded in the time frame between the start of surgery to the end of surgery.
Misop Han, M.D., M.S.
Johns Hopkins Medical Institutions
United States: Institutional Review Board
|Johns Hopkins Hospital||Baltimore, Maryland 21287|