Pilot Study of PEnile TRAnsplantation - Vascularized Composite Allografts

Обзор

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.

Вмешательства

• Процедура Penile transplantation
  The penile transplantation will take place at the Edouard Herriot hospital, part of the Hospices Civils de Lyon. It will be carried out on the same day or the day after the harvesting depending on the timing of the harvesting.

Первичные конечные точки

• Complete functional evaluation [Срок оценки: 24 months]
• Complete functional evaluation [Срок оценки: 24 months]
• Complete functional evaluation [Срок оценки: 24 months]

Вторичные конечные точки (6)

• Complete functional evaluation [Срок оценки: Preoperatively, 6 months and 12 months]
• Complete functional evaluation [Срок оценки: Preoperatively, 6 months and 12 months]
• Complete functional evaluation [Срок оценки: Preoperatively, 6 months and 12 months]
• Postoperative complications [Срок оценки: up to 60 months]
• Qualitive evaluation [Срок оценки: Preoperatively, 6 months, 12 months and 24 months]
• Health-economic evaluation [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Patient ≥ 18 years and ≤ 60 years
• Patient with traumatic penile severe defects (amputation), or congenital penile defects (micropenis)
• ASA ≤ 2
• NYHA ≤ 1
• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 9 центров

• Service d'urologie, andrologie et transplantation rénale Groupe hospitalier Pellegrin Trip — Bordeaux
• Service d'urologie, andrologie et transplantation rénale Hôpital Huriez CHRU Lille — Lille
• Service d'urologie, chirurgie de la transplantation Hôpital Edouard Herriot Hospices Civil — Lyon
• Service de chirurgie urologique et transplantation rénale AP-HM Hôpital de la Conception — Marseille
• Service de chirurgie des brûlés, plastique, reconstructrice et esthétique Polyclinique Sai — Montpellier
• Service néphrologie - soins intensifs - dialyse et transplantation CHU de Montpellier — Montpellier
• Service d'urologie Hôpital Lyon Sud — Pierre-Bénite
• Service d'urologie Hôpital Foch — Suresnes
• … и ещё 1 центр

Идентификаторы

NCT: NCT06781606 · 69HCL22_0906 · 2024-A02180-47

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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