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

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Prostatic Hypertrophy, Benign

Treatments

Device: prostatic photo-vaporization (PVP)

Study type

Interventional

Funder types

Other

Identifiers

NCT01732991

PHAO 2012 - FB / PROPIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

Male

Ages

18+ years old

Volunteers

No 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