Full-house endoscopic sinus surgery with or without nasopharyngeal lymphoid tissue ablation for nasal polyps
Effect of Full-House Endoscopic Sinus Surgery With Versus Without Nasopharyngeal Lymphoid Ablation on Local Mucosal Inflammation in Chronic Rhinosinusitis With Nasal Polyps
NA · Tongji Hospital · NCT07245329
This study will test whether adding nasopharyngeal lymphoid tissue ablation to full-house endoscopic sinus surgery helps adults with nasal polyps have less nasal inflammation and fewer recurrences.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tongji Hospital (other) |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT07245329 on ClinicalTrials.gov |
What this trial studies
In a single-center randomized trial, 32 adults with eosinophilic chronic rhinosinusitis with nasal polyps will be assigned to full-house endoscopic sinus surgery (ESS) alone or ESS plus nasopharyngeal lymphoid tissue ablation. The primary outcome is change in inflammatory cell profiles measured at 1, 3, and 6 months after surgery. Secondary outcomes include inflammatory cytokine levels, symptom scores, endoscopic findings, polyp recurrence rates, and safety measures. Eligibility requires age 18–65 and blood eosinophils >0.3 × 10⁹/L, and all procedures and follow-up visits occur at Tongji Hospital in Wuhan.
Who should consider this trial
Good fit: Adults aged 18–65 with eosinophilic chronic rhinosinusitis with nasal polyps (CRSwNP) who are surgical candidates and have a blood eosinophil count >0.3 × 10⁹/L are the ideal candidates.
Not a fit: Patients with cystic fibrosis, primary ciliary dyskinesia, immunodeficiency, systemic vasculitis/granulomatous disease, recent upper respiratory infection, or other significant comorbidities are excluded and are unlikely to benefit from this specific approach.
Why it matters
Potential benefit: If successful, the addition of nasopharyngeal lymphoid tissue ablation could reduce mucosal inflammation and lower polyp recurrence, improving symptoms and potentially reducing the need for repeat surgery.
How similar studies have performed: Full-house ESS is an established surgical approach for CRSwNP, but adding nasopharyngeal lymphoid tissue ablation is a relatively novel strategy with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18-65 years * Diagnosed with CRSwNP according to EPOS criteria * Blood eosinophil count \> 0.3 × 10⁹/L Exclusion Criteria: * Pregnant or lactating women. * Cystic fibrosis * primary ciliary dyskinesia * fungal ball rhinosinusitis * systemic vasculitis or granulomatous disease * malignancy * immunodeficiency. * Subjects with an upper-respiratory-tract infection within the past 4 weeks. * Clinically significant metabolic, cardiovascular, immune, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disorders, or any condition that, in the investigator's opinion, could interfere with outcome assessment or compromise patient safety. * Currently participating in another clinical trial or having participated in one within 30 days, or staff directly involved in this study.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (RECRUITING)
Study contacts
- Study coordinator: Yin Yao
- Email: Dr.yaoyin@hotmail.com
- Phone: 86 15071077020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nasal Polyps, Full-House Endoscopic Sinus Surgery, Nasopharyngeal Lymphoid Tissue Ablation