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

Primary Purpose

Prostatic Hypertrophy, Benign

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
prostatic photo-vaporization (PVP)
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hypertrophy, Benign focused on measuring Prostatic Hypertrophy, Benign, Greenlight laser, Prostatic photovaporization, Prostatic MRI, Prostatic contrast-enhanced ultrasound, Urinary irritative signs, Postoperative necrotic area

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chru Tours

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

prostatic photo-vaporization

Arm Description

prostatic photo-vaporization (PVP) surgery with laser Greenlight

Outcomes

Primary Outcome Measures

Evolution of thickness of the average necrotic area
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
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
Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound)

Full Information

First Posted
November 19, 2012
Last Updated
August 31, 2015
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT01732991
Brief Title
Assessing the Impact of the PVP With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
Acronym
PROPIL
Official Title
Assessing the Impact of the Prostatic Photo-vaporization (PVP) With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Hypertrophy, Benign
Keywords
Prostatic Hypertrophy, Benign, Greenlight laser, Prostatic photovaporization, Prostatic MRI, Prostatic contrast-enhanced ultrasound, Urinary irritative signs, Postoperative necrotic area

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prostatic photo-vaporization
Arm Type
Experimental
Arm Description
prostatic photo-vaporization (PVP) surgery with laser Greenlight
Intervention Type
Device
Intervention Name(s)
prostatic photo-vaporization (PVP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evolution of thickness of the average necrotic area
Description
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.
Time Frame
J0 (immediately after surgery) M1, M6 and M12
Secondary Outcome Measure Information:
Title
Evolution of urinary irritative signs over 12 months
Description
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)
Time Frame
J0, M1, M6 and M12
Title
Evolution of prostatic volume over 12 months
Description
Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound)
Time Frame
J0, M1, M6 and M12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck BRUYERE, MD
Organizational Affiliation
CHRU TOURS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chru Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

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

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