Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 3
- 试验地点
- 18
- 主要终点
- Complete functional evaluation
研究概览
简要总结
Penile transplantation (PT) has recently emerged as an option for penile reconstruction and has shown encouraging outcomes at the international level with two ongoing PT program (US, South Africa). Emergence of such option has been possible thanks to the development of vascularized composite allotransplantation and because of the important limitations of autologous reconstruction (phalloplasty). Feasibility has already been proven, but the surgical management remains in its infancy and has never been tested at a European level. Furthermore, the balance between functional improvement and immunosuppressive risk still needs to be enlightened.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years and ≤ 60 years
- •Patient with traumatic penile severe defects (amputation), or congenital penile defects (micropenis)
- •Creatinine clearance > 60 mL/min (CKD-EPI)
- •Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- •Informed consent signed to participate to the study
排除标准
- •Gender incongruence
- •Congenital penile defects resulting from exstrophy/epispadias
- •Penile malformation due to selh-half/self-amputation
- •Amputation for penile cancer
- •Other types of malignancy in remission for less than 5 years
- •Progressive malignant tumor
- •Presenting hepatitis B, hepatitis C, or HIV infection not controlled by appropriate anti-viral therapy
- •Uncontrolled arterial hypertension
- •Moderate renal failure : glomerular filtration rate of less than 60 mL/min per 1.73 m2
- •EBV sero-negative recipient with EBV sero-positive graft, due to the risk of lymphoma
- •Non controlled chronic infection
- •Malignancy, Connective tissue disease
- •Amyloidosis
- •Unbalanced diabetes
- •Patient with a contraindication to performing an MRI examination
- •Contra-indication of Thymoglobuline: Hypersensitivity to rabbit proteins or to any of the excipients of Thymoglobuline, acute or chronic infections that contraindicate any additional immunosuppression,
- •Contra-inducation of tacrolimus: Hypersensitivity to tacrolimus or others macrolides, or any of the excipients of PROGRAF,
- •Contra-indication of Mycophenolate mofetil: in patients with hypersensitivity to mycophenolate mofetil, mycophenolic acid or any of the excipients, Hypersensitivity reactions to mycophenolate mofetil;
- •History of major psychiatric disorders < 3 years (psychotic disorders, severe substance abuse, severe personality disorders) or persons under psychiatric care ;
- •Person deprived of their liberty by a judicial or administrative decision ;
- •Person admitted to a health or social institution for purposes other than research
- •Adult subjects to a legal protection measure (guardianship, curatorship)
- •Person not affiliated to a social security scheme of beneficiaries of a similar scheme
结局指标
主要结局
Complete functional evaluation
时间窗: 24 months
Complete functional evaluation after penile transplantation, including the different function of the phallus : Urinary function (uroflowmetry, post-voiding residual voluma and Urinary Symptom Profile (USP®) );
次要结局
- Complete functional evaluation(Preoperatively, 6 months and 12 months)
- Postoperative complications(up to 60 months)
- Qualitive evaluation(Preoperatively, 6 months, 12 months and 24 months)
- Health-economic evaluation(24 months)