The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Study Overview
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Brief Summary
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The treatment of eosinophilic sinusitis with nasal polyps is difficult and challenging. After endoscopic sinus surgery(ESS), complications such as edema, scar formation, adhesions, sinus stenosis and recurrence of polyps are prone to occur. Investigators aim to assess the efficacy and safety of Steroid-eluting stent when implanted in sinus in patients following ESS with eosinophilic sinusitis and nasal polyps.The randomized, double-blind, controlled clinical trial enrolled patients with eosinophilic sinusitis and nasal polyps. After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus and the other side as a control. Primary outcomes are change in the Lund-Kennedy endoscopic score.The primary outcomes will be measured in baseline, week4,week 8 and week 12. Secondary outcomes include the changes in symptoms measured by Visual analog score and nasal patency (nasal airway resistance and nasal cavity volume), exhaled nasal nitric oxide. The investigators also evaluate change in inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor-β, Leukotriene,Eotaxin) in nasal secretions. The secondary outcomes will be measured in baseline, week4, week8 and week12. Mucosal pathology assessment will be performed at 4 weeks postoperatively.Sinus CT scan will be conducted at 8 weeks after surgery. Changes in serum cortisol are monitored at baseline,week4 and week12 postoperatively. All adverse events are recorded throughout the experiment

Official Title
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The Effects of Steroid-eluting Stent Implant for the Treatment of Patients Undergoing Sinus Surgery for Eosinophilic Chronic Rhinosinusitis With Nasal Polyps

Conditions
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Patients, Sinusitis, Nasal Polyps

Intervention / Treatment
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* Procedure: Steroid-eluting stent implant
* Procedure: Without Steroid-eluting stent implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects were 18-65 years old, male or non-pregnant women; Understands the purpose and procedures of the trial and voluntarily signs the informed consent form; Subjects must meet the guidelines for the diagnosis of chronic sinusitis and nasal polyps (EPOS2012), diagnosed with bilateral chronic sinusitis and nasal polyps. Histopathological examination showed a percentage of eosinophils >27%. Planned sinus surgery includes bilateral sinus opening surgery, the same equipment should be used on both sides, FESS surgery must be successfully completed, and no complications; Female subjects were not in the lactation period during the screening visit and had no breastfeeding and pregnancy plan for up to 1 year after the start of the operation; Subjects did not participate in other clinical trials for the first three months and agreed not to participate in other clinical trials until the end of the trial was reached. Exclusion Criteria: The subject has a known allergic reaction or contraindication to the device material and its degradation products (mamethasone citrate, L-polylactic acid, racemic polylactic acid, lactide lactate, lactic acid); Subjects need long-term oral steroid drugs; The subject is receiving immunotherapy for immunosuppressive or autoimmune diseases; Subjects have severe diabetes or Hypertension; Subjects have suffered or are suffering from glaucoma or ocular hypertension; Subjects have cataracts; Patients with acute bacterial sinusitis and acute fungal sinusitis;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steroid-eluting stent implant<br>The ESS procedure had to be successfully completed without complication on both sides. Steroid-eluting stent were implanted in one side of ethmoid sinus and frontal sinus randomly. | Procedure: Steroid-eluting stent implant<br>* After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus.<br>|
| Sham Comparator: Without Steroid-eluting stent implant<br>The ESS procedure had to be successfully completed without complication on both sides. The side without the stent is defined as the control side. | Procedure: Without Steroid-eluting stent implant<br>* After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus. And the side without the stent is defined as the control side.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the Lund-Kennedy endoscopic score | We used the Lund-Kennedy endoscopic scoring system to measure the patient's nasal cavity based on fi there were edema, vesicles, adhesions, scars and polyps. | Baseline, week4,week 8 and week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes in nasal symptoms | Nasal symptoms measured by Visual analog score. The four nasal symptoms (nasal obstruction, rhinorrhea, headache and olfactory disorder) involved in assigning the total nasal symptom score(TNSS). The symptoms are graded on a10-point scale (0 = no symptoms;10 = most severe symptoms). | Baseline, week2, week4, week8, week12 | 
| Nasal patency | Acoustic rhinometry was performed to measure the total nasal cavity volume (cm³) and Rhinomanometer was used to measure the total nasal airway resistance (Pa·cm-³·s-1) . | Baseline, week4, week8 and week12 | 
| Exhaled nasal nitric oxide | Measure exhaled nasal nitric oxide (nNO). Briefly, NO-free air was aspirated through the nasal cavity at a flow rate of 50 ml/s. The subject exhaled against the air-resistance, resulting in an intraoral pressure to close the velum and prevent mixture of oral and nasal gas. Nasal gas from this circuit was continuously routed in part directly into the analyser for determination of nNO, and the level of nNO(ppb) was calculated from a plateau lasting for at least 3s. | Baseline, week4, week8 and week12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic sinus surgery, Eosinophilic sinusitis with nasal polyps, Steroid-eluting stent, Randomized Trial