In-Clinic Endoscopic Polypectomy for Nasal Polyps

Recruiting at 4 trial locations

Overseen By Andrea Lasso, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Must not be taking: Oral corticosteroids, Nasal decongestants

Disqualifiers: Pregnancy, Immunodeficiency, Cystic fibrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new, less expensive method to treat chronic sinusitis with polyps, a condition that often causes ongoing facial pain, headaches, and difficulty breathing through the nose. Researchers aim to determine if removing nasal polyps in a clinic (endoscopic polypectomy in clinic, or EPIC) is as effective as traditional sinus surgery performed in a hospital. If successful, the trial could lead to quicker, more affordable treatments. Individuals with chronic sinusitis with polyps who have not found relief from medication might be suitable candidates, especially if they are considering surgery. As an unphased trial, this study offers patients the chance to contribute to innovative treatment options that could transform future care.

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 prior data suggests that this in-clinic endoscopic polypectomy is safe for treating nasal polyps?

Research shows that the safety of endoscopic polypectomy in clinic (EPIC) looks promising. Studies have used a tool called a microdebrider to remove nasal polyps with local anesthesia in EPIC. This method resembles Functional Endoscopic Sinus Surgery (FESS), known for its safety and effectiveness.

When examining the safety of Endoscopic Sinus Surgery (ESS), studies indicate it is generally safe and effective. It has a high success rate, ranging from 76% to 97.5%, and a low recurrence rate of chronic sinus issues, about 6%.

Both EPIC and ESS are considered safe options. ESS has a long-standing safety record. EPIC is newer but shows similar safety to FESS, which is reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EPIC treatment for nasal polyps because it offers a less invasive alternative to traditional surgery. Unlike endoscopic sinus surgery (ESS), which requires an operating room and anesthesia, EPIC can be performed directly in the clinic, potentially reducing recovery time and healthcare costs. This approach could make treatment more accessible and convenient for patients, which are key reasons for the enthusiasm surrounding this technique.

What evidence suggests that this trial's treatments could be effective for chronic sinusitis?

Research shows that a procedure called in-clinic polypectomy (EPIC), which participants in this trial may receive, offers a promising way to treat nasal polyps. Studies indicate that EPIC provides symptom relief similar to traditional sinus surgery performed in an operating room. EPIC also costs less and allows for quicker recovery. In contrast, endoscopic sinus surgery (ESS), another treatment option in this trial, is a well-established method that improves the quality of life for people with chronic sinus issues. Although ESS is effective, many patients experience a return of symptoms and may require additional surgery. Both treatments have their advantages, but EPIC might be a more affordable and convenient option for some patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Shaun Kilty, MD

Principal Investigator

The Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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, United States, European Union for the following indications:

Approved in Canada as EPIC for:

• Chronic rhinosinusitis with nasal polyps

Approved in United States as Endoscopic Sinus Surgery for:

• Chronic rhinosinusitis with nasal polyps
• Tumors
• Cerebrospinal fluid rhinorrhea
• Encephalocele
• Posterior epistaxis
• Allergic fungal sinusitis

Approved in European Union as FESS for:

• Chronic rhinosinusitis with nasal polyps
• Tumors
• Cerebrospinal fluid rhinorrhea
• Encephalocele
• Posterior epistaxis
• Allergic fungal sinusitis

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

Published Research Related to This Trial

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 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]

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]

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 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]

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 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]

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