Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

Peter Delaney

Status: Completed

Conditions: Prostate Cancer

Treatments: Device: Endomicroscopy

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00792961

13082008

Details and patient eligibility

About

The study involves use of a device called an endomicroscope to obtain high resolution images of microscopic structures during robot-assisted prostate cancer surgery. This feasibility study is largely descriptive, and will use endomicroscopy to document the cellular and architectural appearance of tissue during minimally invasive prostate surgery for later comparison with features seen upon conventional histopathological examination of biopsies or resection specimens.

Full description

Prostate surgery requires meticulous dissection around nerves and associated structures such as the bladder, seminal vesicles and vas deferens. Nerve damage during prostatectomy can result in undesirable outcomes such as impotence and urinary incontinence. Robot assisted minimally invasive prostatectomy offers enhanced visualisation of the surgical field. Superior clinical outcomes in terms of length of hospital stay, blood loss, and oncologic margins compared with open surgery are reported. Confocal endomicroscopy provides high resolution subsurface cellular imaging in real time and is already in clinical use in gastroenterology and under investigation in other surgical applications. A potential role exists for confocal endomicroscopy to enhance microscopic nerve identification intra-operatively and guide surgical decision making during robot-assisted prostatectomy.

Enrollment: 10 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males diagnosed with prostate cancer and undergoing da Vinci radical prostatectomy

Exclusion criteria

• Patients under 18 years of age
• Patients with allergy or prior adverse reaction to Fluorescein Sodium
• Patients unable to give informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Endomicroscopy

Experimental group

Description:

Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery

Treatment:

Device: Endomicroscopy