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

Официальное название

Effect of Full-House Endoscopic Sinus Surgery With Versus Without Nasopharyngeal Lymphoid Ablation on Local Mucosal Inflammation in Chronic Rhinosinusitis With Nasal Polyps

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Numbers and Proportions of Nasal Mucosa inflammatory cells in Patients With Nasal Polyps at Baseline and 1, 3, and 6 Months After Surgery [Срок оценки: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.]

Вторичные конечные точки (8)

• Inflammatory Cytokine Levels in Nasal Secretions Post - surgery [Срок оценки: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.]
• Total VAS Score and Symptom - specific VAS Scores Post - surgery [Срок оценки: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.]
• Nasal Endoscopy Scores [Срок оценки: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.]
• SNOT - 22 Score Changes Post - surgery [Срок оценки: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.]
• Polyp Recurrence Post-surgery [Срок оценки: Focus on the first 6 months post-surgery, with extended monitoring continuing up to 24 months.]
• Rate of Reoperation [Срок оценки: Focused on 6 months post-surgery; continued monitoring to 24 months post-surgery.]
• Postoperative Rescue Treatment Medication Use [Срок оценки: Within 6 months post-surgery.]
• Postoperative Complications [Срок оценки: Within 6 months after surgery.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07245329 · TJ-IRB202506055

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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