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

NCT07245329 | Recruiting

• 1 other identifier: TJ-IRB202506055
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasal Polyps

Keywords

Full-House Endoscopic Sinus Surgery; Nasopharyngeal Lymphoid Tissue Ablation

Outcome Measures

Primary Outcomes (1)

• Numbers and Proportions of Nasal Mucosa inflammatory cells in Patients With Nasal Polyps at Baseline and 1, 3, 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).

  At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.

Secondary Outcomes (8)

• 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.

• Polyp Recurrence Post-surgery

  Focus on the first 6 months post-surgery, with extended monitoring continuing up to 24 months.

Study Arms (2)

Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue Ablation

EXPERIMENTAL

Procedure: Nasopharyngeal Lymphoid Tissue Ablation; Procedure: Full-House Endoscopic Sinus Surgery

Full-House Endoscopic Sinus Surgery

ACTIVE COMPARATOR

Procedure: Full-House Endoscopic Sinus Surgery

Interventions

Nasopharyngeal Lymphoid Tissue Ablation PROCEDURE

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.

Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue Ablation

Full-House Endoscopic Sinus Surgery PROCEDURE

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.

Full-House Endoscopic Sinus Surgery; Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue Ablation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yin Yao

CONTACT

86 15071077020; Dr.yaoyin@hotmail.com

Xing-Liang Wu

CONTACT

86 15131662389; 15131662389@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology-Head & Neck Surgery; Deputy Dean of Institute of Allergy and Clinical Immunology

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: November 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

CN (1)