Effect of Full-House ESS With Nasopharyngeal Lymphoid Tissue Ablation on Nasal Polyps
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nasopharyngeal Lymphoid Tissue Ablation, Full-House Endoscopic Sinus Surgery.
- Who it may be relevant to
- Registry conditions: Nasal Polyps. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Full-House Endoscopic Sinus Surgery With Versus Without Nasopharyngeal Lymphoid Ablation on Local Mucosal Inflammation in Chronic Rhinosinusitis With Nasal Polyps
Overview
This study is designed to evaluate whether the addition of nasopharyngeal lymphoid tissue ablation to full-house endoscopic sinus surgery (ESS) provides superior control of nasal mucosa inflammation compared to full-house ESS alone in patients with nasal polyps. Thirty-two adult participants will be randomly assigned to undergo either full-house ESS only or full-house ESS combined with nasopharyngeal lymphoid tissue ablation. The primary outcome will be assessed through changes in inflammatory cell profiles at 1, 3, and 6 months postoperatively. Secondary outcomes include inflammatory cytokine levels, symptom scores, endoscopic findings, polyp recurrence rates, and safety measures.
Interventions
- Procedure Nasopharyngeal Lymphoid Tissue Ablation
The nasal mucosa is initially decongested using a topical vasoconstrictor. A small-caliber urethral catheter is then introduced through each nasal cavity to elevate the soft palate. A 45° rigid nasoendoscope is inserted transorally to visualize the nasopharynx. Under endoscopic guidance, the nasopharyngeal lymphoid tissue is identified on the nasopharyngeal roof. Following aspiration of any secretions, the tissue is completely resected with a plasma scalpel. - Procedure Full-House Endoscopic Sinus Surgery
After complete removal of the nasal polyps, a full ethmoidectomy is performed, removing all bony septa within the sinuses. Conventional sphenoidotomy and frontal sinusotomy are carried out, with or without preservation of the middle turbinate. Only irreversibly polypoid mucosa is resected, while normal mucosa is preserved.
Primary outcome measures
- Numbers and Proportions of Nasal Mucosa inflammatory cells in Patients With Nasal Polyps at Baseline and 1, 3, and 6 Months After Surgery [Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.]
Secondary outcome measures (8)
- Inflammatory Cytokine Levels in Nasal Secretions Post - surgery [Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.]
- Total VAS Score and Symptom - specific VAS Scores Post - surgery [Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.]
- Nasal Endoscopy Scores [Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.]
- SNOT - 22 Score Changes Post - surgery [Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.]
- Polyp Recurrence Post-surgery [Time frame: Focus on the first 6 months post-surgery, with extended monitoring continuing up to 24 months.]
- Rate of Reoperation [Time frame: Focused on 6 months post-surgery; continued monitoring to 24 months post-surgery.]
- Postoperative Rescue Treatment Medication Use [Time frame: Within 6 months post-surgery.]
- Postoperative Complications [Time frame: Within 6 months after surgery.]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07245329 · TJ-IRB202506055