Assessing the Impact of the Prostatic Photo-vaporization (PVP) With Greenlight Laser Using Prostatic MRI and Contrast-enhanced Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evolution of thickness of the average necrotic area
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
prostatic photo-vaporization
prostatic photo-vaporization (PVP) surgery with laser Greenlight
干预措施: prostatic photo-vaporization (PVP) (Device)
结局指标
主要结局
Evolution of thickness of the average necrotic area
时间窗: 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.
次要结局
- Evolution of urinary irritative signs over 12 months(J0, M1, M6 and M12)
- Evolution of prostatic volume over 12 months(J0, M1, M6 and M12)