Assessing the Impact of the PVP With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound (PROPIL)

This study is currently recruiting participants.
Verified November 2012 by University Hospital, Tours
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01732991
First received: November 19, 2012
Last updated: November 26, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Prostatic Hypertrophy, Benign
Device: prostatic photo-vaporization (PVP)

Study Type: Interventional
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

Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 10
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)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient over 40 years old without an upper age limit
  • Informed orally and in writing, having signed a consent which match to the research
  • Patient with a benign prostatic hypertrophy requiring surgical treatment by PVP
  • Person affiliated to a social security system

Exclusion Criteria:

  • Contraindications to MRI for patients with:

    • ocular metallic foreign object
    • any electronic medical device implanted by irremovable way (pacemakers, neuro-stimulator, cochlear implants ...)
    • metallic heart valve, old heart valves are specially an absolute contraindication because of risk of dysfunction
    • vascular clips implanted formerly on brain aneurysm
  • Allergy to Gadolinium
  • Contraindications to the contrast medium Sonovue:

    • Hypersensitivity to hexafluorinated sulphur or any other components of Sonovue
    • Recent acute coronary syndrome (within 6 months before the intervention)
    • Unstable ischemic heart disease (myocardial infarction being formed or evolving, typical angina of rest in the previous month)
    • Significant worsening of cardiac symptoms between the pre anaesthesia consultation and intervention
    • Recent intervention (less than 6 months) on coronary arteries or other factor suggesting clinical instability (changes in ECG, changes in clinical or biological parameters)
    • Acute heart failure or heart failure stage III or IV
    • Severe arrhythmias
    • Right-left shunt
    • Acute endocarditis
    • Valve prothesis
    • Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg)
    • Systemic hypertension uncontrolled
    • Respiratory distress syndrome
  • Prostatic biopsy < 30 days or anal pathology
  • Patient with prostate cancer
  • Patient with a urinary infection
  • Patient with preoperative urinary catheter
  • Patient with a contraindication for surgery
  • Adult patient with a legal protection measure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732991

Contacts
Contact: Franck BRUYERE, MD 0234389542 f.bruyere@chu-tours.fr
Contact: Thomas BODIN darwu@live.fr

Locations
France
Chru Tours Recruiting
Tours, France, 37044
Contact: Franck BRUYERE, MD    0234389542    f.bruyere@chu-tours.fr   
Contact: Thomas BODIN       darwu@live.fr   
Principal Investigator: Franck BRUYERE, MD         
Sub-Investigator: Aurore BLEUZEN, MD         
Sub-Investigator: Laurent BRUNEREAU, MD         
Sub-Investigator: Thomas BODIN         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Franck BRUYERE, MD CHRU TOURS
  More Information

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01732991     History of Changes
Other Study ID Numbers: PHAO 2012 - FB / PROPIL
Study First Received: November 19, 2012
Last Updated: November 26, 2012
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Tours:
Prostatic Hypertrophy, Benign
Greenlight laser
Prostatic photovaporization
Prostatic MRI
Prostatic contrast-enhanced ultrasound
Urinary irritative signs
Postoperative necrotic area

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hypertrophy
Prostatic Diseases
Genital Diseases, Male
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 15, 2014