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

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.

Study Overview

• Status: Recruiting
• Conditions: Nasal Polyps
• Intervention / Treatment: Procedure: Nasopharyngeal Lymphoid Tissue Ablation; Procedure: Full-House Endoscopic Sinus Surgery

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yin Yao; Phone Number: 86 15071077020; Email: Dr.yaoyin@hotmail.com
• Study Contact Backup: Name: Xing-Liang Wu; Phone Number: 86 15131662389; Email: 15131662389@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Yin Yao; Phone Number: 86 15071077020; Email: Dr.yaoyin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue Ablation	Procedure: 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.; Procedure: 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.
Active Comparator: Full-House Endoscopic Sinus Surgery	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Cytokine Levels in Nasal Secretions Post - surgery	Detection of inflammatory cytokine levels (e.g., IL - 5, IL - 13) in nasal secretions. Samples are collected via nasal swab, then processed and analyzed using immunoassay techniques (e.g., ELISA).	At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
Total VAS Score and Symptom - specific VAS Scores Post - surgery	Evaluate total VAS score and individual symptoms (nasal obstruction, mucopurulent discharge, postnasal drip, headache/dizziness, facial fullness, hyposmia/anosmia, sneezing, sleep disturbance, fatigue, general discomfort). Scores are self - reported by patients using a 0 - 10 scale.	At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
Nasal Endoscopy Scores	Assess nasal endoscopy scores. The scoring includes signs such as nasal polyps, mucosal edema, secretions, crusting, and scarring. Trained clinicians perform nasal endoscopy at each time point following a standardized protocol and record scores based on the presence and severity of these signs.	At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
SNOT - 22 Score Changes Post - surgery	Assess quality - of - life symptoms (nasal discharge, sneezing, rhinorrhea, cough, postnasal drip, purulent discharge, smell/taste disturbance, nasal obstruction/congestion, ear fullness, dizziness, ear pain, facial pain/pressure, difficulty falling asleep, nighttime awakenings, poor sleep quality, morning fatigue, daytime fatigue, decreased work efficiency, difficulty concentrating, depression/irritability, anxiety, restlessness) via the SNOT - 22 questionnaire.	At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
Polyp Recurrence Post-surgery	Polyp recurrence assessed by nasal endoscopy.	Focus on the first 6 months post-surgery, with extended monitoring continuing up to 24 months.
Rate of Reoperation	Assess the proportion of patients undergoing reoperation within 6 months after surgery. Reoperation is indicated if: Oral methylprednisolone (>2 courses: 3 - week tapering, initial dose 30 mg) fails to control mucosal edema/inflammation (polyp score ≥2) and severe nasal symptoms (≥1 symptom score ≥7);; Confirmed by clinicians.	Focused on 6 months post-surgery; continued monitoring to 24 months post-surgery.
Postoperative Rescue Treatment Medication Use	Record rescue treatment (oral methylprednisolone: days 1-5: 30 mg, days 6-10: 20 mg, days 11-15: 10 mg, days 16-20: 5 mg) initiation for symptom/polyp recurrence.	Within 6 months post-surgery.
Postoperative Complications	Record postoperative complications, including bleeding, infection, and altered Sense of Smell.	Within 6 months after surgery.

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 21, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Full-House Endoscopic Sinus Surgery; Nasopharyngeal Lymphoid Tissue Ablation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Signs and Symptoms; Nasal Polyps
• Other Study ID Numbers: TJ-IRB202506055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No