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Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

Primary Purpose

Recurrent Respiratory Papillomatosis, Extra Oesophageal Reflux, Laryngeal Cyst

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Surgical collection of histology specimen
Performance of immunohistochemical analysis
Sponsored by
University Hospital Ostrava
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Respiratory Papillomatosis focused on measuring recurrent respiratory papillomatosis, extra oesophageal reflux, laryngeal cyst, phonosurgery, oesophageal impedance

Eligibility Criteria

1 Year - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Ostrava

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Recurrent respiratory papillomatosis

Laryngeal cyst - control group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Occurrence of EER (percentage)
The occurrence of extra oesophageal reflux will be assessed in both study groups.

Secondary Outcome Measures

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

Full Information

First Posted
October 29, 2015
Last Updated
February 18, 2019
Sponsor
University Hospital Ostrava
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1. Study Identification

Unique Protocol Identification Number
NCT02592902
Brief Title
Recurrent Respiratory Papillomatosis and Extraesophageal Reflux
Official Title
Recurrent Respiratory Papillomatosis and Extraesophageal Reflux
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Ostrava

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Respiratory Papillomatosis, Extra Oesophageal Reflux, Laryngeal Cyst
Keywords
recurrent respiratory papillomatosis, extra oesophageal reflux, laryngeal cyst, phonosurgery, oesophageal impedance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recurrent respiratory papillomatosis
Arm Type
Active Comparator
Arm 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.
Arm Title
Laryngeal cyst - control group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Surgical collection of histology specimen
Intervention Description
Collection of a histology specimen from the vocal cords and rear laryngeal commissure
Intervention Type
Procedure
Intervention Name(s)
Performance of immunohistochemical analysis
Intervention Description
Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis
Primary Outcome Measure Information:
Title
Occurrence of EER (percentage)
Description
The occurrence of extra oesophageal reflux will be assessed in both study groups.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Presence of pepsin
Description
The presence of pepsin (yes-no) will be assessed in both study groups.
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Formanek, MD
Organizational Affiliation
University Hospital Ostrava
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ostrava
City
Ostrava-Poruba
State/Province
Czech Republic
ZIP/Postal Code
708 52
Country
Czechia

12. IPD Sharing Statement

Citations:
PubMed Identifier
18496162
Citation
Derkay CS, Wiatrak B. Recurrent respiratory papillomatosis: a review. Laryngoscope. 2008 Jul;118(7):1236-47. doi: 10.1097/MLG.0b013e31816a7135.
Results Reference
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PubMed Identifier
19005325
Citation
Gallagher TQ, Derkay CS. Recurrent respiratory papillomatosis: update 2008. Curr Opin Otolaryngol Head Neck Surg. 2008 Dec;16(6):536-42. doi: 10.1097/MOO.0b013e328316930e.
Results Reference
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PubMed Identifier
19284366
Citation
Gallagher TQ, Derkay CS. Pharmacotherapy of recurrent respiratory papillomatosis: an expert opinion. Expert Opin Pharmacother. 2009 Mar;10(4):645-55. doi: 10.1517/14656560902793530.
Results Reference
background
PubMed Identifier
18046565
Citation
Goon P, Sonnex C, Jani P, Stanley M, Sudhoff H. Recurrent respiratory papillomatosis: an overview of current thinking and treatment. Eur Arch Otorhinolaryngol. 2008 Feb;265(2):147-51. doi: 10.1007/s00405-007-0546-z. Epub 2007 Nov 29.
Results Reference
background
PubMed Identifier
1309932
Citation
Kashima HK, Shah F, Lyles A, Glackin R, Muhammad N, Turner L, Van Zandt S, Whitt S, Shah K. A comparison of risk factors in juvenile-onset and adult-onset recurrent respiratory papillomatosis. Laryngoscope. 1992 Jan;102(1):9-13. doi: 10.1288/00005537-199201000-00002.
Results Reference
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PubMed Identifier
16847177
Citation
Maloney EM, Unger ER, Tucker RA, Swan D, Karem K, Todd NW, Reeves WC. Longitudinal measures of human papillomavirus 6 and 11 viral loads and antibody response in children with recurrent respiratory papillomatosis. Arch Otolaryngol Head Neck Surg. 2006 Jul;132(7):711-5. doi: 10.1001/archotol.132.7.711.
Results Reference
background
PubMed Identifier
19050916
Citation
Mammas IN, Sourvinos G, Spandidos DA. Human papilloma virus (HPV) infection in children and adolescents. Eur J Pediatr. 2009 Mar;168(3):267-73. doi: 10.1007/s00431-008-0882-z. Epub 2008 Dec 3.
Results Reference
background
PubMed Identifier
15850681
Citation
McKenna M, Brodsky L. Extraesophageal acid reflux and recurrent respiratory papilloma in children. Int J Pediatr Otorhinolaryngol. 2005 May;69(5):597-605. doi: 10.1016/j.ijporl.2004.11.021.
Results Reference
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Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

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