Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

Recurrent Respiratory Papillomatosis Clinical Trial

Official title:

Recurrent Respiratory Papillomatosis and Extraesophageal Reflux

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592902
• Other study ID #: FNO-ENT-papilomatosis
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: September 2018

Study information

• Verified date: February 2019
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Extra Oesophageal Reflux
• Gastroesophageal Reflux
• Laryngeal Cyst
• Papilloma
• Papillomavirus Infections
• Recurrent Respiratory Papillomatosis
• Respiratory Tract Infections

Intervention

Procedure:
• Surgical collection of histology specimen
Collection of a histology specimen from the vocal cords and rear laryngeal commissure
• Performance of immunohistochemical analysis
Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava	Ostrava-Poruba	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (8)

Derkay CS, Wiatrak B. Recurrent respiratory papillomatosis: a review. Laryngoscope. 2008 Jul;118(7):1236-47. doi: 10.1097/MLG.0b013e31816a7135. Review. — View 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 . Review. — View 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. — View 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. Epub 2007 Nov 29. Review. — View 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. — View 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. — View 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. Review. — View Citation

McKenna M, Brodsky L. Extraesophageal acid reflux and recurrent respiratory papilloma in children. Int J Pediatr Otorhinolaryngol. 2005 May;69(5):597-605. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of EER (percentage)	The occurrence of extra oesophageal reflux will be assessed in both study groups.	36 months
Secondary	Presence of pepsin	The presence of pepsin (yes-no) will be assessed in both study groups.	36 months