Assessing the Impact of the PVP With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound (PROPIL)
Recruitment status was Recruiting
The PVP by Greenlight laser 180W is becoming a potential therapeutic alternative in the treatment of benign prostatic hypertrophy (BPH) as recommended.
The PVP creates a prostatic box after the vaporization of the prostatic tissue of BPH. The underlying prostatic tissue is the site of an ischemic necrosis secondary to the thermal effects of proximity of the PVP. We intend to measure by prostatic MRI and contrast-enhanced ultrasound the necrosis.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Assessing the Impact of the Prostatic Photo-vaporization (PVP) With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound|
- Evolution of thickness of the average necrotic area [ Time Frame: J0 (immediately after surgery) M1, M6 and M12 ] [ Designated as safety issue: No ]The primary outcome measure is the measurement of the thickness of the average necrotic area in millimeters on prostatic monitoring MRI and contrast-enhanced ultrasound (no hypothesis in this descriptive study). The variables will be collected immediately after surgery as well as M1, M6 and M12.
- Evolution of urinary irritative signs over 12 months [ Time Frame: J0, M1, M6 and M12 ] [ Designated as safety issue: No ]Evolution of urinary irritative signs over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound): score of IPSS questionary, results of the examination (binary variable)
- Evolution of prostatic volume over 12 months [ Time Frame: J0, M1, M6 and M12 ] [ Designated as safety issue: No ]Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound)
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||May 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: prostatic photo-vaporization
prostatic photo-vaporization (PVP) surgery with laser Greenlight
Device: prostatic photo-vaporization (PVP)
Prostatic photo-vaporization using a lithium laser of 532nm wavelength (GREEN-LIGHT XPS™,American Medical Systems, Minnetonka, MN, USA) emitting by a fiber MoXy™ a maximum power of 180 W continuously. Using common practice and according to the CE labelling.
The laser PVP with an optical fiber firing side carries out a vaporization of next prostatic tissue and a necrosis of underlying prostatic tissue which corresponds to a postoperative inflammatory area.
One of the side effects of this technique is the irritative syndrome which may involve urinary frequency, urgency or burning urination in approximately 10 to 20% at 1 month.
The current literature does report neither the analysis of the underlying inflammatory necrotic area in prostatic vaporized tissue, nor the analysis of the urinary irritative signs post-laser PVP.
Progresses in the field of functional ultrasound imaging allow us to consider a study of evolution of the underlying necrotic area devoid of micro-vascularisation under effect of PVP laser. The parallel with results of MRI (radiological technique most referenced) during the same period would help to support the experimental results of prostatic contrast-enhanced ultrasound.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732991
|Contact: Franck BRUYERE, MDemail@example.com|
|Contact: Thomas BODINfirstname.lastname@example.org|
|Tours, France, 37044|
|Contact: Franck BRUYERE, MD 0234389542 email@example.com|
|Contact: Thomas BODIN firstname.lastname@example.org|
|Principal Investigator: Franck BRUYERE, MD|
|Sub-Investigator: Aurore BLEUZEN, MD|
|Sub-Investigator: Laurent BRUNEREAU, MD|
|Sub-Investigator: Thomas BODIN|
|Principal Investigator:||Franck BRUYERE, MD||CHRU TOURS|