First Clinical Study of Erbium-YAG Laser Vaporisation of Cutaneous Neurofibromas
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- The aim of this study is to enhance the quality of life (measured by the Nottingham Health Profile the Rosenberg's Self-Esteem Scale and the SF-36 health survey) of patients suffering from disfigurement due to thousands of cutaneous neurofibromas.
研究概览
简要总结
The purpose of this study is to determine whether multiple cutaneous neurofibromas in patients with neurofibromatosis type 1 can be removed with an erbium-YAG-laser.
详细描述
With a prevalence of 1 in 3-5000 births, neurofibromatosis Type I is one of the most common genetic defects. The mode of inheritance is autosomal dominant and affects a gene (NF1), which is responsible for the production of the tumor suppressor protein neurofibromin. The consequence is an uninhibited expansion of neural tissue which leads amongst others to cosmetic disfigurement of the patients. In comparison to the plexiform neurofibromas the cutaneous tumors do not undergo malignant transformation.
Excision and CO2 laser vaporisation were established as standard treatment but cause unattractive scars.
In one operation more than 500 neurofibromas can be removed with an Erbium: YAG laser (2940 nm). The tumors are dissected by shooting holes into the skin and vaporising the neurofibromas in-between or underneath. Specimen are harvested after Er: YAG-, CO2 - and electrosurgical treatment to evaluate the difference of thermal necrosis histologically and photographs are taken to assess the cosmetic results.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with multiple cutaneous neurofibromas with the request for tumor removal
排除标准
- •Pregnancy
结局指标
主要结局
The aim of this study is to enhance the quality of life (measured by the Nottingham Health Profile the Rosenberg's Self-Esteem Scale and the SF-36 health survey) of patients suffering from disfigurement due to thousands of cutaneous neurofibromas.
时间窗: 6 months
The standardized questionnaires are done before and 6 month after the operation in which the tight tumor cluster are phased down and thereby an almost normal skin appearance is achieved.
次要结局
- With this new method we want to decrease the painfulness, accelerated the time till wound healing as well as reduce the stay in hospital and the incidence of side effects.(6 months)