Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

University Hospital Ostrava

Status: Completed

Conditions: Extra Oesophageal Reflux; Recurrent Respiratory Papillomatosis; Laryngeal Cyst

Treatments: Procedure: Performance of immunohistochemical analysis; Procedure: Surgical collection of histology specimen

Study type: Interventional

Funder types: Other

Identifiers

NCT02592902

FNO-ENT-papilomatosis

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Recurrent respiratory papillomatosis

Active Comparator group

Description:

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.

Treatment:

Procedure: Surgical collection of histology specimen

Procedure: Performance of immunohistochemical analysis

Laryngeal cyst - control group

Active Comparator group

Description:

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.

Treatment:

Procedure: Surgical collection of histology specimen

Procedure: Performance of immunohistochemical analysis