In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps
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|ClinicalTrials.gov Identifier: NCT02975310|
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : September 22, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Sinusitis Nasal Polyps||Procedure: Endoscopic polypectomy in clinic (EPIC) Procedure: Endoscopic Sinus Surgery (ESS) Other: General Anesthesia Other: Local and topical anesthesia||Not Applicable|
Chronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity having a health state utility value equivalent to end-stage renal disease. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment.
However, the wait time to receive surgical treatment (ESS) maybe up to 8 months or longer, with a cost to the Government of $3500/ESS procedure. The annual direct cost of CRS is estimated at $860 million with an overall financial impact of 1.3 billion dollars per year for Canada. Endoscopic polypectomy in clinic (EPIC), a potential disruptive innovation, is a drastically deescalated form of ESS performed in clinic instead of the operating room. EPIC appears to provide quality of life (QofL) improvement equivalent to that reported for ESS. EPIC has a shorter wait time and lower cost to a government, i.e. nearly one-tenth of ESS or about $450. A pilot economic evaluation study demonstrated that EPIC was cost-effective compared to ESS. This has created a controversy about which treatment should be employed for these patients. Further, a recent Cochrane review identified the need for high-quality randomised controlled trials to determine if ESS has additional benefit over polypectomy as there is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRS with polyps.
The proposed national multicenter randomised controlled trial will determine whether EPIC is non-inferior to the current treatment standard, ESS, in QofL improvement for patients with CRS with polyps. It will also assess the cost-effectiveness of performing EPIC in place of ESS. The investigators hypothesize that EPIC will be non-inferior to ESS for QofL improvement while reducing health care cost. This would imply that EPIC is a dominant strategy and that the ESS strategy represents over-treatment in this patient population. The study findings would position EPIC into the current CRS treatment paradigm thereby transforming care and reducing costs both nationally and internationally.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Polypectomy Performed In Clinic for Chronic Rhinosinusitis With Polyps: The EPIC Randomised Controlled Trial|
|Actual Study Start Date :||April 11, 2017|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2025|
Experimental: Endoscopic polypectomy in clinic (EPIC)
Patients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic
Procedure: Endoscopic polypectomy in clinic (EPIC)
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.
Other: Local and topical anesthesia
EPIC will be performed under topical and local anesthesia in a clinic setting
Active Comparator: Endoscopic Sinus Surgery (ESS)
Patients assigned to this arm will undergo endoscopic sinus surgery (ESS),
Procedure: Endoscopic Sinus Surgery (ESS)
The control intervention is endoscopic sinus surgery (ESS), 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.
Other: General Anesthesia
ESS will be performed under general anesthesia in the operating room
- Sinonasal Outcome Test-22 (SNOT-22) [ Time Frame: 3 months ]
- Peak Nasal Inspiratory Flow (PNIF): [ Time Frame: 3 months ]
- Iowa Satisfaction with Anesthesia Scale (ISAS) [ Time Frame: 3 months ]Patient satisfaction with anesthesia for the treatment procedure
- Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) [ Time Frame: 3 months ]Work Impairment related to chronic rhinosinusitis
- EQ-5D-5L [ Time Frame: 3 months ]Quality of Life
- Participant Health Resource Consumption Survey [ Time Frame: 3 months ]Individual Health Resource Consumption
- Adverse Events [ Time Frame: 3 months ]
- Lund-Kennedy Endoscopic Scoring Scale [ Time Frame: 3 months ]Endoscopic inflammation of the nose and paranasal sinuses after treatment
- Visual Analogue Scale (VAS) for satisfaction with assigned procedure [ Time Frame: 3 months ]Satisfaction with assigned procedure
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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. 15
- 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.
- Must have nasal blockage score greater than or equal to 2 on the sinonasal outcome test SNOT-22 at the screening visit.
- Must have an American Society of Anesthesiologists physical status PS3 classification or less.
- 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.
- Women who are pregnant or breast feeding as per patient's report
- 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 ESS 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
- Inability to read and understand English
- Any medical condition that in the opinion of the investigator would interfere with the treatment
- Any participant who is unfit to undergo surgery under general anesthesia
- Current participation in another clinical trial at the time of the screening visit.
- Participant is unable to undergo an awake procedure
- Diagnosis or Aspirin Exacerbated Respiratory Disease (AERD)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975310
|Contact: Andrea Lasso, MSc||6137985555 ext firstname.lastname@example.org|
|Canada, British Columbia|
|Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada|
|Contact: Kelly Nguyen email@example.com|
|St. Joseph's Hospital London||Recruiting|
|London, Ontario, Canada, N6A 4V2|
|Contact: Taciano Rocha|
|Ottawa Hospital Research Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y 1J8|
|Contact: Andrea Lasso, MSc 613-798-5555 ext 10222 firstname.lastname@example.org|
|McGill University Health Center||Recruiting|
|Montréal, Quebec, Canada, H4A 3J1|
|Contact: Marc Tewfik|
|Principal Investigator:||Shaun Kilty, MD||The Ottawa Hospital Research Institute|
|Responsible Party:||Ottawa Hospital Research Institute|
|Other Study ID Numbers:||
|First Posted:||November 29, 2016 Key Record Dates|
|Last Update Posted:||September 22, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Pathological Conditions, Anatomical
Respiratory Tract Infections
Paranasal Sinus Diseases
Respiratory Tract Diseases
Central Nervous System Depressants
Physiological Effects of Drugs