Pilot Study of The EPIC Trial

NCT02533206 | Active Not Recruiting DMC

• 1 other identifier: 20150487-01H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief Summary

Chronic sinusitis is one of the most common chronic diseases in North America, with over 5% of the Canadian population affected by the disease. Until now, treatment with surgery has been performed only in the operating room. Recently a smaller surgical procedure that is done in the clinic for some patients with chronic sinusitis with polyps has been found to result in symptom control that appears to be similar to that which occurs with sinus surgery. Performing the smaller clinical procedure has advantages including a shorter recovery time for the patient, a much lower cost to the health care system for the procedure, and a shorter patient wait time for the procedure to be done in comparison to sinus surgery performed in the operating room. To know with greater certainty that the procedure performed in the clinic is as good as the operating room sinus surgery, a large multiple investigator randomised clinical trial has been designed. However, before carrying out that trial, a practice run or internal pilot study of that trial is required to ensure that the trial can recruit patients at the rate that is anticipated and that the procedures to obtain the measurements being used for the larger study are adequate.

Conditions

Sinusitis; Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Rate of recruitment

  Number of patients recruited in one year

  One year

Secondary Outcomes (2)

• Arm cross-over

  One year

• Loss to follow up

  Evaluated at 6 months after intervention

Study Arms (2)

EPIC

EXPERIMENTAL

The experimental intervention is endoscopic polypectomy performed in clinic (EPIC) where nasal polyps are removed using a microdebrider under local and topical anesthesia in the outpatient clinic. The participant will be discharged home from the clinic following their procedure.

Procedure: Endoscopic Polypectomy Performed in Clinic

FESS

ACTIVE COMPARATOR

The control intervention is functional endoscopic sinus surgery (FESS), a minimally invasive procedure that is the current standard that involves polypectomy with a microdebrider as well as sinus ostia enlargement of the affected sinuses performed in the operating room under general anesthesia

Procedure: Functional Endoscopic Sinus Surgery (FESS)

Interventions

Endoscopic Polypectomy Performed in Clinic PROCEDURE

Endoscopic polypectomy performed in clinic under local and topical anesthesia

Also known as: EPIC

EPIC

Functional Endoscopic Sinus Surgery (FESS) PROCEDURE

Functional Endoscopic Sinus Surgery

Also known as: FESS

FESS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• 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. 21
• Bilateral nasal polyps present of Grade ≥ 2 on each side as determined by the Lildholdt scale score measured by nasal endoscopy (Appendix 2) at the screening visit.
• Must have nasal blockage score greater than or equal to 4 on the sinonasal outcome test SNOT-22 (Appendix 3) at the screening visit.
• Must have an American Society of Anesthesiologists physical status (ASA PS) 3 classification or less. ASA PS 3: Patients with severe systemic disease: Some functional limitation; has a controlled disease of more than one body system or one major system; no immediate danger of death. ASA PS 2: Patients with mild systemic disease. No functional limitations; has a well-controlled disease of one body system. ASA PS 1: Normal healthy patient. No organic, physiologic, or psychiatric disturbance; excludes the very young and very old.
• 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.
• 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.

You may not qualify if:

• Women who are pregnant or breast feeding
• Patients with hyperplastic polyps or polyps large enough that they result in external nasal deformity
• Facial pain/pressure score higher than 2 on the sinonasal outcome test SNOT-22 at the screening visit.
• History of any surgical procedure that prevents the ability to accurately grade the nasal polyps
• Participants who will not be able to complete the follow-up appointments/evaluations
• Have significant oral structural abnormalities, e.g. unrepaired cleft palate
• Septal deviation requiring correction in order to perform either EPIC or FESS procedures
• Diagnosis of an immunodeficiency or immunocompromised state
• Diagnosis of cystic fibrosis
• Diagnosis of allergic fungal sinusitis
• 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)
• History of either Churg-Strauss syndrome, primary ciliary dyskinesia, or vasculitis (e.g. granulomatosis with polyangiitis(GPA))
• Allergy, hypersensitivity, or contraindication to the use of local or topical lidocaine anesthetics, nasal topical 1:1000 adrenaline, nasal decongestants, nasal steroid spray
• 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
• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (5)

Royal Victoria Hospital

Barrie, Ontario, L4M 6M2, Canada

Location

St Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Algoma District Medical Group

Sault Ste. Marie, Ontario, P6B 1Y5, Canada

Location

Saint Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (2)

• Rudmik L, Smith KA, Kilty S. Endoscopic polypectomy in the clinic: a pilot cost-effectiveness analysis. Clin Otolaryngol. 2016 Apr;41(2):110-7. doi: 10.1111/coa.12473. Epub 2016 Feb 4.

  PMID: 26053107 BACKGROUND

• Kilty SJ. In-clinic endoscopic polypectomy for chronic rhinosinusitis with polyps: a treatment strategy pilot study in ten adults. Clin Otolaryngol. 2015 Jun;40(3):281-4. doi: 10.1111/coa.12372. No abstract available.

  PMID: 25581621 BACKGROUND

MeSH Terms

Conditions

Sinusitis; Nasal Polyps

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Shaun Kilty, MD, FRCSC

  The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 6, 2015
• First Posted: August 26, 2015
• Study Start: August 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

CA (5)