Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

February 18, 2019 updated by: University Hospital Ostrava
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • Czech Republic
      • Ostrava-Poruba, Czech Republic, Czechia, 708 52
        • University Hospital Ostrava

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Surgical collection of histology specimen
Collection of a histology specimen from the vocal cords and rear laryngeal commissure
Procedure: Performance of immunohistochemical analysis
Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis
Active Comparator: 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.
Procedure: Surgical collection of histology specimen
Collection of a histology specimen from the vocal cords and rear laryngeal commissure
Procedure: Performance of immunohistochemical analysis
Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Ostrava

Investigators

  • Principal Investigator: Martin Formánek, MD, University Hospital Ostrava

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

October 29, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNO-ENT-papilomatosis

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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