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

Prostatic Hypertrophy, Benign Clinical Trial

— PROPIL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732991
• Other study ID #: PHAO 2012 - FB / PROPIL
• Status: Completed
• Phase: N/A
• First received: November 19, 2012
• Last updated: August 31, 2015
• Start date: September 2012
• Est. completion date: March 2015

Study information

• Verified date: August 2015
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophy
• Prostatic Hyperplasia
• Prostatic Hypertrophy, Benign

Intervention

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.

Locations

Country	Name	City	State
France	Chru Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	J0 (immediately after surgery) M1, M6 and M12	No
Secondary	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)	J0, M1, M6 and M12	No
Secondary	Evolution of prostatic volume over 12 months	Evolution of prostatic volume over 12 months (prostatic monitoring MRI and contrast-enhanced ultrasound)	J0, M1, M6 and M12	No