Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP

Efficacy of Anti-IL-5 Therapy Combined With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery in Patients With CRSwNP: A Multicenter Randomized Controlled Trial

This study compares two surgical approaches combined with anti-IL-5 therapy in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Patients will be randomly assigned to one of the three groups: (1) anti-IL-5 alone, (2) anti-IL-5 with simple polyp removal, or (3) anti-IL-5 with extended sinus surgery. The aim of this study is to see if a less invasive surgery (simple polyp removal) with anti-IL-5 works as well as more extensive surgery with anti-IL-5. Participants will be followed for 1 to 3 years.

Inclusion Criteria:

1. Endoscopy shows bilateral nasal polyps, with bilateral NPS ≥4 (≥2 per side)
2. Nasal obstruction symptoms >3 months, nasal obstruction score ≥2 (total 3 points) and/or hyposmia ≥2 (maximum 3 points)
3. Evidence of type 2 inflammation: Nasal polyp tissue Eos >55/HPF or >27% of inflammatory cells; or Peripheral blood Eos ≥6.9% (without asthma) or ≥3.7% (with asthma) Note: Meet any 2 of the above 3 criteria
4. Failure after 4 weeks of standard medical therapy including: Intranasal corticosteroids >4 weeks; Other agents (oral steroids, macrolides, antihistamines, leukotriene receptor antagonists, decongestants, antibiotics) permitted as needed

Exclusion Criteria:

1. Cystic fibrosis, Young's syndrome, Kartagener syndrome, antrochoanal polyp, or rhinitis medicamentosa
2. Acute upper respiratory infection within 2 weeks
3. Asthma exacerbation within 1 month
4. HIV infection
5. Parasitic infection within 6 months
6. History of hypersensitivity to investigational drugs (except aspirin intolerance)
7. Hypersensitivity to monoclonal antibodies or anti-IL-5 agents
8. Oral steroid therapy within 1 month
9. Pregnancy planning, current pregnancy, or lactation
10. Uncontrolled systemic diseases
11. Have a history of previous sinus surgery for CRSwNP
12. Significant septal deviation affecting unilateral ventilation (mild deviation allowed)
13. Investigator judgment of unsuitability for cohort study