Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Location status: Recruiting
NCT Number: NCT07245329
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Wuhan, Hubei, 430030, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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).
Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after 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).
Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after 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.
Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
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.
Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after 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.
Time frame: Focus on the first 6 months post-surgery, with extended monitoring continuing up to 24 months.
Polyp recurrence assessed by nasal endoscopy.
Time frame: Focused on 6 months post-surgery; continued monitoring to 24 months post-surgery.
Assess the proportion of patients undergoing reoperation within 6 months after surgery. Reoperation is indicated if:
Time frame: Within 6 months post-surgery.
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.
Time frame: Within 6 months after surgery.
Record postoperative complications, including bleeding, infection, and altered Sense of Smell.
Contact information is provided by the study sponsor or research team.
Xing-Liang Wu
CONTACT
Yin Yao
CONTACT
Tongji Hospital
Other
Effect of Full-House Endoscopic Sinus Surgery With Versus Without Nasopharyngeal Lymphoid Ablation on Local Mucosal Inflammation in Chronic Rhinosinusitis With Nasal Polyps
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