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

Tongji Hospital

Status

Enrolling

Conditions

Nasal Polyps

Treatments

Procedure: Full-House Endoscopic Sinus Surgery

Procedure: Nasopharyngeal Lymphoid Tissue Ablation

Study type

Interventional

Funder types

Other

Identifiers

NCT07245329

TJ-IRB202506055

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.