Skip to main content
OpenTrials
Completed

NCT Number: NCT02592902

Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Recurrent Respiratory Papillomatosis Extra Oesophageal Reflux Laryngeal Cyst

Age range

1 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava

Ostrava-Poruba, Czech Republic, 708 52, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical collection of histology specimen

Procedure

Collection of a histology specimen from the vocal cords and rear laryngeal commissure

Performance of immunohistochemical analysis

Procedure

Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis

Primary outcomes

  1. Occurrence of EER (percentage)

    Time frame: 36 months

    The occurrence of extra oesophageal reflux will be assessed in both study groups.

Secondary outcomes

  1. Presence of pepsin

    Time frame: 36 months

    The presence of pepsin (yes-no) will be assessed in both study groups.

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Oct 30, 2015
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.