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Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy

Phase 0
35 Years
75 Years
Not Enrolling
Prostate Cancer

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Trial Information

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
navigational aid.

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.

Inclusion Criteria:

- Patients must be scheduled for a robotic LRP

- Patients must be between the ages of 35 and 75

- Patients must not have one of the listed exclusion criteria

- Patients must be able to understand and willing to adhere to the study protocol

- Patients must have a clinical stage diagnosis of T1 or T2

- Patients must have a preoperative serum PSA < 20ng/ml

- Patients must have a biopsy Gleason score of 5-8

Exclusion Criteria:

- Patients less than 35 years of age and over 75 years of age.

- Patients with previous rectal surgery

- Patients with anal stenosis that prevents the TRUS probe insertion

- Patients with extensive abdominal surgery

- Patients with inadequate bowel prep

- Patients who are unwilling or unable to sign informed consent

- Patients on anticoagulation medication (eg. coumadin, lovenox, or heparin)

- Patients with a clinical stage diagnosis of T3 - Patients with a preoperative serum
PSA ≥ 20 ng/mL

- Patients with a biopsy Gleason score < 5 or > 8

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Accuracy of TRUS Robot and 3-D TRUS navigation software.

Outcome Description:

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.

Outcome Time Frame:

Measurements will be recorded in the time frame between the start of surgery to the end of surgery.

Safety Issue:


Principal Investigator

Misop Han, M.D., M.S.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Medical Institutions


United States: Institutional Review Board

Study ID:




Start Date:

August 2009

Completion Date:

June 2013

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Prostatectomy
  • Transrectal Ultrasound
  • Tandem RALP
  • Prostatic Neoplasms



Johns Hopkins HospitalBaltimore, Maryland  21287