Assessing the Impact of the PVP With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
NCT ID: NCT01732991
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2012-09-30
2015-03-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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prostatic photo-vaporization
prostatic photo-vaporization (PVP) surgery with laser Greenlight
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Franck BRUYERE, MD
Role: PRINCIPAL_INVESTIGATOR
CHRU TOURS
Locations
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Chru Tours
Tours, , France
Countries
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References
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Bruyere F, Bodin T, Bleuzen A, Patat F, Brunereau L. Penetration depth with the XPS GreenLight laser assessed by contrast enhanced ultrasonography. J Endourol. 2013 Oct;27(10):1282-6. doi: 10.1089/end.2013.0368. Epub 2013 Aug 21.
Other Identifiers
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PHAO 2012 - FB / PROPIL
Identifier Type: -
Identifier Source: org_study_id