Clinical trial NCT02592902: Recurrent Respiratory Papillomatosis and Extraesophageal Reflux
Official title: Recurrent Respiratory Papillomatosis and Extraesophageal Reflux
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Respiratory Papillomatosis
Extra Oesophageal Reflux
Laryngeal Cyst
Keywords: recurrent respiratory papillomatosis
extra oesophageal reflux
laryngeal cyst
phonosurgery
oesophageal impedance
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Occurrence of EER (percentage)
timeFrame: 36 months
Secondary outcomes:
measure: Presence of pepsin
timeFrame: 36 months
Other outcomes:
Locations:
city: Ostrava-Poruba
country: Czechia
facility: University Hospital Ostrava
state: Czech Republic
Study officials:
affiliation: University Hospital Ostrava
name: Martin Formanek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Derkay CS, Wiatrak B. Recurrent respiratory papillomatosis: a review. Laryngoscope. 2008 Jul;118(7):1236-47. doi: 10.1097/MLG.0b013e31816a7135.
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.
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.
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.
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.
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.
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.
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.