Effect of Full-House Endoscopic Sinus Surgery With Versus Without Nasopharyngeal Lymphoid Ablation on Local Mucosal Inflammation in Chronic Rhinosinusitis With Nasal Polyps
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Numbers and Proportions of Nasal Mucosa inflammatory cells in Patients With Nasal Polyps at Baseline and 1, 3, and 6 Months After Surgery
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-65 years
- •Diagnosed with CRSwNP according to EPOS criteria
- •Blood eosinophil count > 0.3 × 10⁹/L
排除标准
- •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.
研究组 & 干预措施
Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue Ablation
干预措施: Nasopharyngeal Lymphoid Tissue Ablation (Procedure)
Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue Ablation
干预措施: Full-House Endoscopic Sinus Surgery (Procedure)
Full-House Endoscopic Sinus Surgery
干预措施: Full-House Endoscopic Sinus Surgery (Procedure)
结局指标
主要结局
Numbers and Proportions of Nasal Mucosa inflammatory cells in Patients With Nasal Polyps at Baseline and 1, 3, and 6 Months After Surgery
时间窗: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
Sampling of the ethmoid sinus mucosa from patients after surgery is performed under nasal endoscopic guidance; nasopharyngeal swabs are used to collect samples from the nasopharynx. The method for nasopharyngeal sampling is as follows: The subject sits in a seated position, blows their nose, and closes their eyes before swab sample collection to facilitate relaxation and ease of sampling. A professional doctor gently inserts the nasal swab into one nostril along the bottom of the nasal cavity (parallel to the hard palate) until it reaches the nasopharynx, then rotates the swab approximately five times in the nasopharynx. The swab is placed into a collection tube containing 2 mL of RPMI medium. One nasopharyngeal swab is collected per donor each time. After processing, flow cytometry is used for analysing the numbers and proportions of inflammatory cells (including T cells, B cells, Plasma cells, Eosinophils, and Neutrophils).
次要结局
- Polyp Recurrence Post-surgery(Focus on the first 6 months post-surgery, with extended monitoring continuing up to 24 months.)
- Postoperative Complications(Within 6 months after surgery.)
- Inflammatory Cytokine Levels in Nasal Secretions Post - surgery(At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.)
- Total VAS Score and Symptom - specific VAS Scores Post - surgery(At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.)
- Nasal Endoscopy Scores(At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.)
- SNOT - 22 Score Changes Post - surgery(At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.)
- Rate of Reoperation(Focused on 6 months post-surgery; continued monitoring to 24 months post-surgery.)
- Postoperative Rescue Treatment Medication Use(Within 6 months post-surgery.)
研究者
Yin Yao
Professor of Otolaryngology-Head & Neck Surgery; Deputy Dean of Institute of Allergy and Clinical Immunology
Tongji Hospital