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

NCT ID: NCT07245329

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Nasal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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

Group Type EXPERIMENTAL

Nasopharyngeal Lymphoid Tissue Ablation

Intervention Type 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

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Full-House Endoscopic Sinus Surgery

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yin Yao

Professor of Otolaryngology-Head & Neck Surgery; Deputy Dean of Institute of Allergy and Clinical Immunology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yin Yao

Role: CONTACT

86 15071077020

Xing-Liang Wu

Role: CONTACT

86 15131662389

Facility Contacts

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Yin Yao

Role: primary

86 15071077020

Other Identifiers

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TJ-IRB202506055

Identifier Type: -

Identifier Source: org_study_id

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