Nasal PolypsNCT07245329
Effect of Full-House ESS With Nasopharyngeal Lymphoid Tissue Ablation on Nasal Polyps
A study testing Nasopharyngeal Lymphoid Tissue Ablation and Full-House Endoscopic Sinus Surgery in people with Nasal Polyps, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nasal Polyps
- What is being tested?
- Nasopharyngeal Lymphoid Tissue Ablation and Full-House Endoscopic Sinus Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years
- Diagnosed with CRSwNP according to EPOS criteria
- Blood eosinophil count > 0.3 × 10⁹/L
Who cannot join
- Pregnant or lactating women.
- Cystic fibrosis
- primary ciliary dyskinesia
- fungal ball rhinosinusitis
- systemic vasculitis or granulomatous disease
- malignancy
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Yin Yao, 86 15071077020, Dr.yaoyin@hotmail.com
About this study
Official title: 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.
- Conditions
- Nasal Polyps
- Being tested
- Nasopharyngeal Lymphoid Tissue Ablation, Full-House Endoscopic Sinus Surgery
- Keywords
- Full-House Endoscopic Sinus Surgery, Nasopharyngeal Lymphoid Tissue Ablation
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasopharyngeal Lymphoid Tissue AblationProcedure or surgery
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 SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue Ablation | Experimental | Not described Receives: Procedure: Nasopharyngeal Lymphoid Tissue Ablation; Procedure: Full-House Endoscopic Sinus Surgery |
| Full-House Endoscopic Sinus Surgery | Active comparator | Not described Receives: Procedure: Full-House Endoscopic Sinus Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
Polyp Recurrence Post-surgery
Polyp recurrence assessed by nasal endoscopy.
Measured: 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.
Measured: 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.
Measured: Within 6 months post-surgery.
Postoperative Complications
Record postoperative complications, including bleeding, infection, and altered Sense of Smell.
Measured: Within 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jul 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yin Yao, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245329
- Sponsor's protocol ID
- TJ-IRB202506055
- Status last verified
- Nov 2025
- First submitted
- 21 Sep 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Full-House Endoscopic Sinus Surgery With Versus Without Nasopharyngeal Lymphoid Ablation on Local Mucosal Inflammation in Chronic Rhinosinusitis With Nasal Polyps
- ClinicalTrials.gov ID
- NCT07245329
- Acronym / sponsor ID
- TJ-IRB202506055
- Conditions
- Nasal Polyps
- Keywords
- Full-House Endoscopic Sinus Surgery, Nasopharyngeal Lymphoid Tissue Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-65 years
- Diagnosed with CRSwNP according to EPOS criteria
- Blood eosinophil count > 0.3 × 10⁹/L
Key exclusion criteria (10 listed)
- Pregnant or lactating women.
- Cystic fibrosis
- primary ciliary dyskinesia
- fungal ball rhinosinusitis
- systemic vasculitis or granulomatous disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasopharyngeal Lymphoid Tissue AblationThe 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 or surgery | Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue Ablation |
| Full-House Endoscopic Sinus 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. | Procedure or surgery | Full-House Endoscopic Sinus Surgery, Full-House Endoscopic Sinus Surgery Combined with Nasopharyngeal Lymphoid Tissue Ablation |
Primary outcome
Numbers and Proportions of Nasal Mucosa inflammatory cells in Patients With Nasal Polyps at Baseline and 1, 3, and 6 Months After Surgery
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).
8 secondary outcomes
Inflammatory Cytokine Levels in Nasal Secretions Post - surgery
Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
Total VAS Score and Symptom - specific VAS Scores Post - surgery
Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
Nasal Endoscopy Scores
Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
SNOT - 22 Score Changes Post - surgery
Time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.
Polyp Recurrence Post-surgery
Time frame: Focus on the first 6 months post-surgery, with extended monitoring continuing up to 24 months.
Rate of Reoperation
Time frame: Focused on 6 months post-surgery; continued monitoring to 24 months post-surgery.
Postoperative Rescue Treatment Medication Use
Time frame: Within 6 months post-surgery.
Postoperative Complications
Time frame: Within 6 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasopharyngeal Lymphoid Tissue Ablation and Full-House Endoscopic Sinus Surgery in people with Nasal Polyps, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yin Yao (86 15071077020, Dr.yaoyin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers and Proportions of Nasal Mucosa inflammatory cells in Patients With Nasal Polyps at Baseline and 1, 3, and 6 Months After Surgery (time frame: At baseline (before surgery) and 1 month, 3 months, and 6 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.