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Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease

Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00215787
Enrollment
20
Registered
2005-09-22
Start date
2005-09-30
Completion date
2008-09-30
Last updated
2010-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux, Nasal Polyps

Keywords

Nasal polyps, Gastroesophageal Reflux

Brief summary

Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%. The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy.

Detailed description

Although nasal polyposis has been recognized as an inflammatory process for many years, the true etiology of nasal polyposis mainly unknown. Despite surgical removal, the recurrence rate after surgery has been reported as high as 87% within the first year after surgery. Anecdotally the Principal Investigator found an incidence of pH probe-proven laryngopharyngeal reflux approaching 80% in his patients with nasal polyposis. Although his number of cases was small, the incidence of recurrence of polyps in these patients was 17%. The PI believes that such an association is too great to be explained by chance alone, and deserves further study. He anticipates two contributions to the literature from this study, the first documenting the incidence of extraesophageal (laryngopharyngeal) reflux in patients with polyposis, and the second showing the impact of reflux treatment on the recurrence rate of the polyps, initially after one year of therapy. Eligible patients found to have nasal polyps will be offered the chance to participate in this study. They will undergo non-invasive pH probe monitoring for 24 hours. If extraesophageal (laryngopharyngeal) reflux is discovered, they will be provided (at no cost) proton pump inhibitor medication (PPI), prescribed in accordance with published standards in the otolaryngology literature. Their polyposis will be treated as any other patient presenting with polyposis; participation in the study will not affect the course of polyp treatment. The incidence of recurrence will be monitored and recorded over the first year after treatment. Included: Subjects will be adults with nasal polyposis, recruited from the PI's private practice, will not be currently taking a PP!, will be able and willing to undergo a noninvasive 24 hour pH probe study, and willing to take a PPI. Excluded: patients who are pregnant, have a history of surgical treatment for reflux disease, history of allergic or adverse reaction to Prevacid or adverse reaction to Prevacid during the study period, and those not meeting inclusion criteria. In addition to routine office otolaryngology examination, subjects will undergo noninvasive 24 hour esophageal pH probe monitoring. The probe is swallowed and placed in the same manner as a feeding tube. The procedure is done in the office. No sedation is required, but the mucosa may be sprayed with topical 4% lidocaine for comfort. This procedure is the standard for diagnosis of extraesophageal (laryngopharyngeal) reflux, and will be performed in accordance with manufacturer guidelines Risks include temporary dysphagia while the probe is in place, and nasal irritation. Mild, self-limited epistaxis has been rarely reported The procedure will be done within manufcturer guidelines under direct vision. Topical Afrin may be used to control any mild epistaxis. Topical 4% lidocaine will be applied to minimize dysphagia. These steps have proven very affective in minimizing these risks. If the study hypothesis is correct, the patient may have an diminished risk of recurrence of their nasal polyposis. If the patient is found to have previously undiagnosed reflux disease, this will allow it to be treated appropriately. Undiagnosed/untreated reflux has been associated with multiple medical problems including laryngeal and esophageal cancer. The patient will be given their PPI medication free of charge for the duration of the study. The noninvasive pH probe study will be done free of charge. No direct monetary payment will be given to participants.

Interventions

DRUGlansoprazole

Lansoprazole 30 mg BID for 1 year

Sponsors

Head and Neck Surgery Associates
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Subjects will: * Be adults with nasal polyposis * recruited from the PI's private practice * Not be currently taking a PPI * Be able and willing to undergo a noninvasive 24 hour pH probe study; and * Take a PPI.

Exclusion criteria

Patients who: * Are pregnant * Have a history of surgical treatment for reflux disease * History of allergic or adverse reaction to Prevacid or adverse reaction to Prevacid during the study period; and * Do not meet inclusion criteria.

Design outcomes

Primary

MeasureTime frameDescription
Presence of Reflux in Patients With Polyposisone yearPresence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards.

Countries

United States

Participant flow

Participants by arm

ArmCount
Lansoprazole
Lansoprazole 30mg BID for one year
20
Total20

Baseline characteristics

CharacteristicLansoprazole
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
Region of Enrollment
United States
20 participants
Sex: Female, Male
Female
12 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Presence of Reflux in Patients With Polyposis

Presence of Laryngopharyngeal reflux was measured by 24 hour pH impedance probe monitor per equipment manufacturer software. Two or more episodes in twenty four hours was considered positive, in accordance with published standards.

Time frame: one year

ArmMeasureValue (NUMBER)
LansoprazolePresence of Reflux in Patients With Polyposis15 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026