Clinical trial NCT03943121: The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Official title: The Effects of Steroid-eluting Stent Implant for the Treatment of Patients Undergoing Sinus Surgery for Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients
Sinusitis
Nasal Polyps
Keywords: Endoscopic sinus surgery
Eosinophilic sinusitis with nasal polyps
Steroid-eluting stent
Randomized Trial
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: China-Japan Union Hospital, Jilin University
First posted: 2019-05-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. Subjects were 18-65 years old, male or non-pregnant women;
2. Understands the purpose and procedures of the trial and voluntarily signs the informed consent form;
3. 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%.
4. 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;
5. 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;
6. 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:

1. 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);
2. Subjects need long-term oral steroid drugs;
3. The subject is receiving immunotherapy for immunosuppressive or autoimmune diseases;
4. Subjects have severe diabetes or Hypertension;
5. Subjects have suffered or are suffering from glaucoma or ocular hypertension;
6. Subjects have cataracts;
7. Patients with acute bacterial sinusitis and acute fungal sinusitis;

Primary outcomes:
measure: The change in the Lund-Kennedy endoscopic score
timeFrame: Baseline, week4,week 8 and week 12
Secondary outcomes:
measure: The changes in nasal symptoms
timeFrame: Baseline, week2, week4, week8, week12
measure: Nasal patency
timeFrame: Baseline, week4, week8 and week12
measure: Exhaled nasal nitric oxide
timeFrame: Baseline, week4, week8 and week12
Other outcomes:
measure: 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.
timeFrame: Baseline, week4, week8 and week12
measure: Mucosal pathology assessment
timeFrame: Week4
measure: Sinus CT scan
timeFrame: Week 8
measure: Changes in serum cortisol
timeFrame: Baseline,week4 and week12
measure: Adverse events
timeFrame: Week2, week4, week8, week12
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
References: