RecruitingNot ApplicableNCT07245329

Effect of Full-House ESS With Nasopharyngeal Lymphoid Tissue Ablation on 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

Sponsor

Tongji Hospital

Enrollment

32 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

Nasal Polyps

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

Aged 18-65 years
Diagnosed with CRSwNP according to EPOS criteria
Blood eosinophil count \> 0.3 × 10⁹/L

Exclusion Criteria10

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.

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Interventions

PROCEDURENasopharyngeal 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.

PROCEDUREFull-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.