NCT02592902

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

4.3 years

First QC Date

October 29, 2015

Last Update Submit

February 18, 2019

Conditions

Recurrent Respiratory PapillomatosisExtra Oesophageal RefluxLaryngeal Cyst

Keywords

recurrent respiratory papillomatosisextra oesophageal refluxlaryngeal cystphonosurgeryoesophageal impedance

Outcome Measures

Primary Outcomes (1)

  • Occurrence of EER (percentage)

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

    36 months

Secondary Outcomes (1)

  • Presence of pepsin

    36 months

Study Arms (2)

Recurrent respiratory papillomatosis

ACTIVE COMPARATOR

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 specimenProcedure: Performance of immunohistochemical analysis

Laryngeal cyst - control group

ACTIVE COMPARATOR

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 specimenProcedure: Performance of immunohistochemical analysis

Interventions

Surgical collection of histology specimenPROCEDURE

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

Laryngeal cyst - control groupRecurrent respiratory papillomatosis
Performance of immunohistochemical analysisPROCEDURE

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

Laryngeal cyst - control groupRecurrent respiratory papillomatosis

Eligibility Criteria

Age1 Year - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ostrava

Ostrava-Poruba, Czech Republic, 708 52, Czechia

Location

Related Publications (8)

  • Derkay CS, Wiatrak B. Recurrent respiratory papillomatosis: a review. Laryngoscope. 2008 Jul;118(7):1236-47. doi: 10.1097/MLG.0b013e31816a7135.

    PMID: 18496162BACKGROUND

  • 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.

    PMID: 19005325BACKGROUND

  • 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.

    PMID: 19284366BACKGROUND

  • 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.

    PMID: 18046565BACKGROUND

  • 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.

    PMID: 1309932BACKGROUND

  • 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.

    PMID: 16847177BACKGROUND

  • 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.

    PMID: 19050916BACKGROUND

  • 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.

    PMID: 15850681BACKGROUND

MeSH Terms

Conditions

Recurrent respiratory papillomatosis

Study Officials

  • Martin Formanek, MD

    University Hospital Ostrava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

October 30, 2015

Study Start

April 1, 2014

Primary Completion

August 1, 2018

Study Completion

September 1, 2018

Last Updated

February 20, 2019

Record last verified: 2019-02

Locations

CZ(1)