Effect of Full-House ESS With Nasopharyngeal Lymphoid Tissue Ablation on Nasal Polyps
ConditionNasal Polyps
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-65 years
Diagnosed with CRSwNP according to EPOS criteria
Blood eosinophil count > 0.3 × 10⁹/L
Disqualifiers
Pregnant or lactating women.
Cystic fibrosis
primary ciliary dyskinesia
fungal ball rhinosinusitis
Trial design
Design model
Parallel
Treatments tested in this trial
Nasopharyngeal Lymphoid Tissue Ablation
Procedure/SurgeryThe 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
Procedure/SurgeryAfter 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue AblationExperimental treatment 2 interventions
Group B: Full-House Endoscopic Sinus SurgeryActive comparator 1 intervention
Trial outcomes
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).
Time frame
At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.Secondary outcomes
1
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).
Time frame
At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.2
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.
Time frame
At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.3
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.
Time frame
At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.4
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.
Time frame
At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.Sponsors and contacts
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Source ClinicalTrials.gov