Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

Not Applicable

Completed

• Conditions: Recurrent Respiratory Papillomatosis; Extra Oesophageal Reflux; Laryngeal Cyst
• Interventions: Procedure: Surgical collection of histology specimen; Procedure: Performance of immunohistochemical analysis

• Registration Number: NCT02592902
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Primary Completion: 2018-08
• Study Completion: 2018-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laryngeal cyst - control group	Surgical collection of histology specimen	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.
Laryngeal cyst - control group	Performance of immunohistochemical analysis	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.
Recurrent respiratory papillomatosis	Surgical collection of histology specimen	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.
Recurrent respiratory papillomatosis	Performance of immunohistochemical analysis	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.

Primary Outcome Measures

Name	Time	Method
Occurrence of EER (percentage)	36 months	The occurrence of extra oesophageal reflux will be assessed in both study groups.

Secondary Outcome Measures

Name	Time	Method
Presence of pepsin	36 months	The presence of pepsin (yes-no) will be assessed in both study groups.

Trial Locations

Locations (1)

University Hospital Ostrava; 🇨🇿 Ostrava-Poruba, Czech Republic, Czechia