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

August 31, 2015 updated by: University Hospital, Tours

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • Chru Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of thickness of the average necrotic area
Time Frame: J0 (immediately after surgery) M1, M6 and M12
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.
J0 (immediately after surgery) M1, M6 and M12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of urinary irritative signs over 12 months
Time Frame: J0, M1, M6 and M12
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)
J0, M1, M6 and M12
Evolution of prostatic volume over 12 months
Time Frame: J0, M1, M6 and M12
Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound)
J0, M1, M6 and M12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Franck BRUYERE, MD, Chru Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

November 19, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (Estimate)

November 26, 2012

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHAO 2012 - FB / PROPIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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