Recurrent Respiratory Papillomatosis and Extraesophageal Reflux
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Occurrence of EER (percentage)
研究概览
简要总结
The purpose of the study was to determine, whether patients with recurrent respiratory papillomatosis (RRP) suffer from extra oesophageal reflux more often than patients with laryngeal cyst (control group).
详细描述
Recurrent respiratory papillomatosis (RRP) is a chronic viral disease, which affects children and adults as well. It is characterised by grow of squamous cell tumours on mucosa of aerodigestive tract, with predilection for the larynx. The disease is caused by the human papillomavirus (HPV). However, in contrast to the low incidence of RRP, HPV prevalence is common. It is indicated that other factors may contribute to the pathogenesis of RRP. One such factor might be extraesophageal reflux (EER). We investigated whether patients with RRP suffer more often from EER.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 1-75 years
- •cooperating patients with laryngeal papillomatosis
- •patients tolerating impedance probe
- •signed informed consent, consent with the examinations
- •control group of patients with a cyst or vocal cord polyp (reflux finding score 0-2) and/or patients indicated to augmentation, medialization or lateralization of the vocal cords
排除标准
- •patients non-tolerating impedance catheter
- •patients who do not understand Czech language
- •patients who do not proclaim consent with enrolment into the study
- •patients who do not proclaim consent with the planned examinations
- •patients after surgical treatment of tumour of the swallowing or respiratory tract
研究组 & 干预措施
Recurrent respiratory papillomatosis
Patients with recurrent respiratory papillomatosis (RRP) - surgical collection of histology specimen from the vocal cords and rear laryngeal commissure, performance of immunohistochemical analysis - proof of pepsin, HPV 6 and 11, herpes simplex virus (HSV) type 2, chlamydia trachomasis, and assessment of the dysplasia.
干预措施: Surgical collection of histology specimen (Procedure)
Recurrent respiratory papillomatosis
Patients with recurrent respiratory papillomatosis (RRP) - surgical collection of histology specimen from the vocal cords and rear laryngeal commissure, performance of immunohistochemical analysis - proof of pepsin, HPV 6 and 11, herpes simplex virus (HSV) type 2, chlamydia trachomasis, and assessment of the dysplasia.
干预措施: Performance of immunohistochemical analysis (Procedure)
Laryngeal cyst - control group
Patients with laryngeal cyst - surgical collection of a histology specimen from the vocal cords and rear laryngeal commissure, performance of immunohistochemical analysis - proof of pepsin and HPV 6 and 11, herpes simplex virus (HSV) type 2 and chlamydia trachomasis.
干预措施: Surgical collection of histology specimen (Procedure)
Laryngeal cyst - control group
Patients with laryngeal cyst - surgical collection of a histology specimen from the vocal cords and rear laryngeal commissure, performance of immunohistochemical analysis - proof of pepsin and HPV 6 and 11, herpes simplex virus (HSV) type 2 and chlamydia trachomasis.
干预措施: Performance of immunohistochemical analysis (Procedure)
结局指标
主要结局
Occurrence of EER (percentage)
时间窗: 36 months
The occurrence of extra oesophageal reflux will be assessed in both study groups.
次要结局
- Presence of pepsin(36 months)