Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

Conditions
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Recurrent Respiratory Papillomatosis, Extra Oesophageal Reflux, Laryngeal Cyst

Intervention / Treatment
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* Procedure: Surgical collection of histology specimen
* Procedure: Performance of immunohistochemical analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Recurrent respiratory papillomatosis<br>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. | Procedure: Surgical collection of histology specimen<br>* Collection of a histology specimen from the vocal cords and rear laryngeal commissure<br>Procedure: Performance of immunohistochemical analysis<br>* Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis<br>|
| Active Comparator: Laryngeal cyst - control group<br>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. | Procedure: Surgical collection of histology specimen<br>* Collection of a histology specimen from the vocal cords and rear laryngeal commissure<br>Procedure: Performance of immunohistochemical analysis<br>* Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of EER (percentage) | The occurrence of extra oesophageal reflux will be assessed in both study groups. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of pepsin | The presence of pepsin (yes-no) will be assessed in both study groups. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent respiratory papillomatosis, extra oesophageal reflux, laryngeal cyst, phonosurgery, oesophageal impedance