Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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In Vivo Confocal Endomicroscopy During da Vinci Robot Assisted Prostatectomy: Feasibility Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Endomicroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endomicroscopy<br>Endomicroscopy is performed in addition to the patient's indicated robot-assisted prostate surgery | Device: Endomicroscopy<br>* Rigid drop-in endomicroscope imaging probe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endomicroscopy images captured from prostate and surrounding tissues |  | During surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison with conventional histology from corresponding biopsies or resection specimens |  | Post-surgery, after pathologist's review | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Robotic surgery, Endomicroscopy