Actively Recruiting
Effect of Full-House Endoscopic Sinus Surgery With Versus Without Nasopharyngeal Lymphoid Ablation on Local Mucosal Inflammation in Chronic Rhinosinusitis With Nasal Polyps
Led by Tongji Hospital · Updated on 2025-11-24
32
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether adding nasopharyngeal lymphoid tissue ablation to full-house endoscopic sinus surgery (ESS) improves control of nasal mucosa inflammation in adults with nasal polyps. This study will compare the combined procedure to full-house ESS alone in patients diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP). The goal is to understand if the additional ablation can better reduce inflammation and polyp recurrence. Participants will be randomly assigned to one of two groups: one receiving full-house ESS alone and the other receiving full-house ESS combined with nasopharyngeal lymphoid tissue ablation. The ablation procedure involves decongesting the nasal mucosa, using a small catheter to elevate the soft palate, and endoscopically removing the nasopharyngeal lymphoid tissue with a plasma scalpel. The full-house ESS includes removal of nasal polyps, a full ethmoidectomy, sphenoidotomy, and frontal sinusotomy, preserving normal mucosa when possible. Participants will be followed for inflammation and recovery at baseline, 1, 3, and 6 months after surgery. Researchers will assess inflammatory cells, cytokine levels, symptom scores, nasal endoscopy findings, polyp recurrence, medication use, and complications. Polyp recurrence and reoperation rates will be monitored for up to 24 months. Safety and symptom changes will be carefully recorded throughout the study duration.
CONDITIONS
Brief Title
Effect of Full-House ESS With Nasopharyngeal Lymphoid Tissue Ablation on Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-65 years
- Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP) according to EPOS criteria
- Blood eosinophil count greater than 0.3 × 10⁹/L
You will not qualify if you...
- Pregnant or lactating women
- Cystic fibrosis
- Primary ciliary dyskinesia
- Fungal ball rhinosinusitis
- Systemic vasculitis or granulomatous disease
- Malignancy
- Immunodeficiency
- Upper respiratory tract infection within the past 4 weeks
- Significant metabolic, cardiovascular, immune, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disorders that may interfere with outcome or safety
- Currently participating in another clinical trial or participated in one within 30 days
- Staff directly involved in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo full-house endoscopic sinus surgery with or without nasopharyngeal lymphoid tissue ablation. This stage includes the surgery and immediate recovery period post-operation.
1 surgery visit (in-person)
Duration - 6 months
Participants are monitored for recovery and assessment of nasal mucosa inflammation, symptoms, and polyp recurrence.
Visits at 1 month, 3 months, and 6 months after surgery (in-person)
Duration - Up to 24 months
Participants continue to be monitored for polyp recurrence, reoperation rates, and complications up to 24 months after surgery.
Additional visits depending on individual clinical needs (in-person)
Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
Research Team
Y
Yin Yao
X
Xing-Liang Wu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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