In-Clinic Endoscopic Polypectomy for Nasal Polyps

Recruiting at 3 trial locations

Overseen by Shaun Kilty, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Oral corticosteroids, Nasal decongestants

Disqualifiers: Pregnancy, Immunodeficiency, Cystic fibrosis, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and headache, an inability to breath through the nose and complete smell loss, regularly impair one's ability to work and to enjoy and participate in daily activities. The annual cost of chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with polyps, the most common type of chronic sinusitis, is usually treated with a combination of medications and surgery. Until now, surgical treatment has only been performed in the operating room, at a cost of about $3500 per procedure. But, recent studies have shown that a new procedure, "in-clinic polyp removal", can provide an improvement in patient symptoms to levels equal to those for sinus surgery performed in a hospital operating room. Moreover, in clinic polyp removal has additional advantages including a shorter procedure recovery time, a significantly lower cost to the health care system (about one-tenth the cost or $450), and a shorter wait time for treatment. With the proposed pragmatic trial, the investigators will determine whether the in clinic polyp removal procedure is as good as sinus surgery in the operating room at controlling patient symptoms of chronic sinusitis. The investigators will also determine the cost and health-benefits for a patient, the healthcare system and for society of in clinic polyp removal in comparison to sinus surgery done in a hospital operating room. The investigators will then know if this new treatment, in clinic polyp removal, can replace sinus surgery as the standard of care for these patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have asthma or COPD, your condition must be stable without recent exacerbations or steroid use. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Endoscopic Polypectomy for Nasal Polyps?

Research shows that Functional Endoscopic Sinus Surgery (FESS), which is similar to the in-clinic endoscopic polypectomy, is effective for treating nasal polyps and chronic sinusitis, with good results observed in patients after one year. ^{1 2 3 4 5}

Is in-clinic endoscopic polypectomy for nasal polyps safe?

Functional endoscopic sinus surgery (FESS), which is similar to in-clinic endoscopic polypectomy, has been used for over 20 years and is generally considered safe for removing nasal polyps. Studies show that complications are minor and occur in a small percentage of cases. ^{1 2 6 7 8}

How does the treatment for nasal polyps differ from other treatments?

The in-clinic endoscopic polypectomy (EPIC) is unique because it allows for the removal of nasal polyps directly in a clinic setting, potentially offering a more convenient and less invasive option compared to traditional Functional Endoscopic Sinus Surgery (FESS), which is typically performed in an operating room. ^{1 2 3 8 9}

Research Team

Shaun Kilty, MD

Principal Investigator

The Ottawa Hospital Research Institute

Eligibility Criteria

Adults over 18 with chronic sinusitis and nasal polyps, who've tried medical therapy without success. They must be in stable health (not severely ill), not pregnant or breastfeeding, and able to consent. Excluded are those with certain nasal conditions, immune disorders, drug allergies, or unable to follow the study protocol.

Inclusion Criteria

My health is good enough for surgery according to the ASA classification.

I have moderate to severe nasal polyps in both nostrils.

I often have a blocked nose, as per my recent test results.

Exclusion Criteria

I have been diagnosed with allergic fungal sinusitis.

I have nasal polyps that are causing my nose to change shape.

I've had surgery that affects the grading of nasal polyps.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Endoscopic Sinus Surgery (ESS) or Endoscopic Polypectomy in Clinic (EPIC)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Multiple visits (in-person and virtual)

Treatment Details

Interventions

• Endoscopic polypectomy in clinic (EPIC) (Procedure)
• Endoscopic Sinus Surgery (ESS) (Procedure)

Trial Overview The trial is testing if removing nasal polyps in a clinic setting (EPIC) is as effective as traditional surgery under general anesthesia in an operating room for treating chronic sinusitis symptoms. It also compares costs and recovery times between these two methods.

Participant Groups

Group I: Endoscopic polypectomy in clinic (EPIC) Experimental Treatment 2 Interventions

Patients assigned to this arm of the study will undergo the In Clinic Polypectomy Performed in Clinic

Group II: Endoscopic Sinus Surgery (ESS) Active Control 2 Interventions

Patients assigned to this arm will undergo endoscopic sinus surgery (ESS),

Endoscopic polypectomy in clinic (EPIC) is already approved in Canada for the following indications:

Approved in Canada as EPIC for:

• Chronic rhinosinusitis with nasal polyps

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Findings from Research

Functional Endoscopic Sinus Surgery (FESS) is an effective surgical option for patients with chronic sinusitis and nasal polyposis, showing good functional results after one year of follow-up.

In a study of 95 patients (51 with chronic sinusitis and 44 with nasal polyposis), there were no significant differences in outcomes between the two conditions, indicating that FESS is equally beneficial for both.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Functional endoscopic sinus surgery. Evaluation methods and results]. Duquesne, U., Dolhen, P., Hennebert, D.[2009]

Functional endoscopic sinus surgery (FESS) for nasal polyp removal shows a symptomatic improvement rate of 78-88%, which is generally better than 43-84% for other comparative procedures, indicating its effectiveness.

The overall complication rates for FESS range from 0.3% to 22.4%, with major complications being rare (0-1.5%), suggesting that while FESS is relatively safe, there is significant variability in outcomes that warrants further high-quality research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic sinus surgery for the excision of nasal polyps: A systematic review of safety and effectiveness. Dalziel, K., Stein, K., Round, A., et al.[2019]

Functional Endoscopic Sinus Surgery (FESS) is an effective primary treatment for both primary and recurrent nasal polyposis, with a low recurrence rate of only 12.9% within one year among 116 patients studied.

The surgery allows for careful removal of mucosal polyps while preserving nasal mucosa, leading to significant symptom improvement in over 90% of patients, highlighting its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Endoscopic Sinus Surgery as a primary modality of treatment for primary and recurrent nasal polyposis. Gohar, MS., Niazi, SA., Niazi, SB.[2023]

In a study of 72 patients with chronic rhinosinusitis with nasal polyps (CRSwNP), specific cytokines like eotaxin, IL-17A, and RANTES were found to be significantly elevated in patients who experienced postoperative recurrence compared to those who did not.

Eotaxin and RANTES were identified as strong predictors of recurrence, with eotaxin showing an area under the curve (AUC) of 0.729 and RANTES 0.776, suggesting they could serve as valuable biomarkers for monitoring CRSwNP patients after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploration of Predictive Biomarkers for Postoperative Recurrence in Chronic Rhinosinusitis with Nasal Polyps Based on Serum Multiple-Cytokine Profiling. Wang, G., Zheng, H., Chen, X., et al.[2022]

In a study of 221 patients undergoing functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis, older patients showed significantly better compliance with postoperative follow-up compared to younger patients.

The findings suggest that younger patients may need more education about the importance of follow-up care to improve their compliance, as other factors like gender, smoking status, and comorbidities did not significantly affect follow-up rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Age Is Associated With Better Compliance With Follow-up in Taiwan After Functional Endoscopic Sinus Surgery. Tsai, T., Shih, LC., Lee, IT., et al.[2021]

In a study of 70,288 patients who underwent functional endoscopic sinus surgery (FESS) from 2013 to 2017, the overall complication rate was low at 0.50%, indicating that FESS is a safe procedure for treating chronic rhinosinusitis.

The study found that the severity of comorbidities and the status of the hospital were linked to higher complication rates, while having asthma and using a microdebrider were associated with fewer complications, suggesting that patient characteristics can influence surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trends in complications after functional endoscopic sinus surgery in Japan: A comparison with a previous study (2007-2013vs. 2013-2017). Koizumi, M., Suzuki, S., Matsui, H., et al.[2021]

In a study of 21 children undergoing functional endoscopic sinus surgery (FESS) for nasal polyps, 77% reported good subjective outcomes after a mean follow-up of over two years, indicating the procedure's efficacy.

Minor complications occurred in 9.2% of the surgeries, suggesting that FESS is generally safe for children, although previous surgeries for nasal polyps were linked to worse outcomes and higher recurrence rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic sinus surgery for nasal polyps in children: results. Bolt, RJ., de Vries, N., Middelweerd, RJ.[2004]

In a study of 60 patients undergoing functional endoscopic sinus surgery (FESS), dexmedetomidine was found to provide better hemodynamic stability and lower blood loss compared to labetalol, achieving a mean arterial pressure (MAP) target of 65-75 mmHg more effectively.

Patients receiving dexmedetomidine also required significantly less fentanyl for pain management and experienced a longer time before their first request for analgesics, indicating improved postoperative pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

To Compare the Efficacy of Dexmedetomidine Versus Labetalol in Providing Controlled Hypotension in Functional Endoscopic Sinus Surgery. J N, S., Kumar, S., Vijay, T.[2022]

In a study of 10 patients with nasal polyposis, both functional endoscopic sinus surgery (FESS) and simple polypectomy combined with balloon catheter dilatation (BCD) showed significant improvement in symptoms and radiological findings after 12 months, indicating both methods are effective.

There was no significant difference in outcomes between FESS and BCD, suggesting that BCD could be a viable alternative to FESS for treating nasal polyposis, although further long-term studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of outcomes of simple polypectomy plus balloon catheter dilatation versus functional endoscopic sinus surgery in nasal polyposis: a preliminary study. Bozdemir, K., Kutluhan, A., Çetin, H., et al.[2013]

References

1. Belgium pubmed.ncbi.nlm.nih.gov

[Functional endoscopic sinus surgery. Evaluation methods and results]. [2009]

2. United States pubmed.ncbi.nlm.nih.gov

Endoscopic sinus surgery for the excision of nasal polyps: A systematic review of safety and effectiveness. [2019]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Functional Endoscopic Sinus Surgery as a primary modality of treatment for primary and recurrent nasal polyposis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Exploration of Predictive Biomarkers for Postoperative Recurrence in Chronic Rhinosinusitis with Nasal Polyps Based on Serum Multiple-Cytokine Profiling. [2022]

5. Greece pubmed.ncbi.nlm.nih.gov

Older Age Is Associated With Better Compliance With Follow-up in Taiwan After Functional Endoscopic Sinus Surgery. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Trends in complications after functional endoscopic sinus surgery in Japan: A comparison with a previous study (2007-2013vs. 2013-2017). [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Endoscopic sinus surgery for nasal polyps in children: results. [2004]

8. Netherlands pubmed.ncbi.nlm.nih.gov

To Compare the Efficacy of Dexmedetomidine Versus Labetalol in Providing Controlled Hypotension in Functional Endoscopic Sinus Surgery. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of outcomes of simple polypectomy plus balloon catheter dilatation versus functional endoscopic sinus surgery in nasal polyposis: a preliminary study. [2013]