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Trial record 98 of 126 for:    HSV-2

Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02592902
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Recurrent Respiratory Papillomatosis Extra Oesophageal Reflux Laryngeal Cyst Procedure: Surgical collection of histology specimen Procedure: Performance of immunohistochemical analysis Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recurrent Respiratory Papillomatosis and Extraesophageal Reflux
Study Start Date : April 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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




Primary Outcome Measures :
  1. Occurrence of EER (percentage) [ Time Frame: 36 months ]
    The occurrence of extra oesophageal reflux will be assessed in both study groups.


Secondary Outcome Measures :
  1. Presence of pepsin [ Time Frame: 36 months ]
    The presence of pepsin (yes-no) will be assessed in both study groups.



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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592902


Locations
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Czechia
University Hospital Ostrava
Ostrava-Poruba, Czech Republic, Czechia, 708 52
Sponsors and Collaborators
University Hospital Ostrava
Investigators
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Principal Investigator: Martin Formanek, MD University Hospital Ostrava

Publications:

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Responsible Party: University Hospital Ostrava
ClinicalTrials.gov Identifier: NCT02592902     History of Changes
Other Study ID Numbers: FNO-ENT-papilomatosis
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Keywords provided by University Hospital Ostrava:
recurrent respiratory papillomatosis
extra oesophageal reflux
laryngeal cyst
phonosurgery
oesophageal impedance
Additional relevant MeSH terms:
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Respiratory Tract Infections
Papillomavirus Infections
Papilloma
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Infection
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections