Real Time Microscopic Imaging During Robot Assisted Prostate Cancer Surgery

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Endomicroscopy

• Registration Number: NCT00792961
• Lead Sponsor: Peter Delaney

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-16
• Study First Submitted QC: 2008-11-16
• Study First Posted: 2008-11-18
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-07
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Endomicroscopy images captured from prostate and surrounding tissues	During surgery

Secondary Outcome Measures

Name	Time	Method
Comparison with conventional histology from corresponding biopsies or resection specimens	Post-surgery, after pathologist's review

Trial Locations

Locations (1)

The Hospital at Westlake Medical Center; 🇺🇸 Austin, Texas, United States