In-clinic removal of nasal polyps for chronic sinusitis

Endoscopic Polypectomy Performed In Clinic for Chronic Rhinosinusitis With Polyps: The EPIC Randomised Controlled Trial

This study tests if a new in-clinic procedure for removing nasal polyps can help people with chronic sinusitis just as much as the traditional surgery done in an operating room, while being quicker and cheaper.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (Academic / other)
• Locations: 4 sites (Vancouver, British Columbia and 3 other locations)
• Trial ID: NCT02975310 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of in-clinic endoscopic polypectomy (EPIC) as a treatment for chronic rhinosinusitis with nasal polyps. The study compares EPIC to traditional endoscopic sinus surgery (ESS) performed in an operating room, focusing on patient outcomes, cost-effectiveness, and quality of life improvements. Participants will undergo the procedure in a clinical setting, which is expected to reduce wait times and costs significantly. The trial aims to provide high-quality evidence on whether EPIC can match the benefits of ESS while being more accessible and affordable.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with chronic rhinosinusitis with nasal polyps requiring surgical intervention.

Not a fit: Patients with mild nasal polyps or those who have not responded to medical therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide patients with quicker and more cost-effective relief from chronic sinusitis symptoms.

How similar studies have performed: Previous studies have indicated that in-clinic polypectomy may offer similar benefits to traditional surgery, but this trial aims to provide definitive evidence.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years or older
2. Diagnosis of chronic rhinosinusitis with polyps requiring surgical treatment after having been treated with medical therapy as designated by the Canadian clinical practice guidelines for acute and chronic sinusitis. 15
3. Bilateral nasal polyps present of Grade ≥ 2 on each side as determined by the Lildholdt scale score measured by nasal endoscopy at the screening visit.
4. Must have nasal blockage score greater than or equal to 2 on the sinonasal outcome test SNOT-22 at the screening visit.
5. Must have an American Society of Anesthesiologists physical status PS3 classification or less.
6. Participants with comorbid asthma or chronic obstructive pulmonary disease (COPD) must have stable disease with no exacerbations (no emergency room visits, hospitalisations, or oral or parental steroid use for these lower respiratory conditions) within 3 months before the screening visit.
7. Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study. Participants must sign an informed consent document indicating that they understand the purpose of and procedures of the study and are willing to participate in the study.

Exclusion Criteria:

1. Women who are pregnant or breast feeding as per patient's report
2. Patients with hyperplastic polyps or polyps large enough that they result in external nasal deformity
3. Facial pain/pressure score higher than 2 on the sinonasal outcome test SNOT-22 at the screening visit.
4. History of any surgical procedure that prevents the ability to accurately grade the nasal polyps
5. Participants who will not be able to complete the follow-up appointments/evaluations
6. Have significant oral structural abnormalities, e.g. unrepaired cleft palate
7. Septal deviation requiring correction in order to perform either EPIC or ESS procedures
8. Diagnosis of an immunodeficiency or immunocompromised state
9. Diagnosis of cystic fibrosis
10. Diagnosis of allergic fungal sinusitis
11. Contraindication to the use of oral corticosteroids (e.g. uncontrolled diabetes, congestive heart failure, uncontrolled hypertension, known renal insufficiency, known peptic ulcer disease, known glaucoma, pregnancy)
12. History of either Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis (e.g. granulomatosis with polyangiitis(GPA))
13. Allergy, hypersensitivity, or contraindication to the use of local or topical lidocaine anesthetics, nasal topical 1:1000 adrenaline, nasal decongestants, nasal steroid spray
14. Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator, could confound the results of the study or could interfere with the participant's participation or compliance with the study
15. A recent (within 1 year of the screening visit) clinically significant history of drug or alcohol abuse, or dependence that, in the opinion of the investigator could interfere with the participant's participation or compliance with the study
16. Inability to read and understand English
17. Any medical condition that in the opinion of the investigator would interfere with the treatment
18. Any participant who is unfit to undergo surgery under general anesthesia
19. Current participation in another clinical trial at the time of the screening visit.
20. Participant is unable to undergo an awake procedure
21. Diagnosis or Aspirin Exacerbated Respiratory Disease (AERD)

Where this trial is running

Vancouver, British Columbia and 3 other locations

• Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
• St. Joseph's Hospital London — London, Ontario, Canada (Recruiting)
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
• McGill University Health Center — Montreal, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Shaun Kilty, MD — Ottawa Hospital Research Institute
• Study coordinator: Andrea Lasso, MSc

Conditions Sinusitis; Nasal Polyps