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

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ClinicalTrials.gov Identifier: NCT03943121
Recruitment Status : Recruiting
First Posted : May 9, 2019
Last Update Posted : June 4, 2019
Sponsor:
Collaborators:
First Affiliated Hospital, Sun Yat-Sen University
China-Japan Union Hospital, Jilin University
Information provided by (Responsible Party):
Beijing Tongren Hospital

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


Condition or disease Intervention/treatment Phase
Patients Sinusitis Nasal Polyps Procedure: Steroid-eluting stent implant Procedure: Without Steroid-eluting stent implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Steroid-eluting Stent Implant for the Treatment of Patients Undergoing Sinus Surgery for Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Sinusitis

Arm Intervention/treatment
Experimental: Steroid-eluting stent implant
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
After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus.

Sham Comparator: Without Steroid-eluting stent implant
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
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.




Primary Outcome Measures :
  1. The change in the Lund-Kennedy endoscopic score [ Time Frame: Baseline, week4,week 8 and week 12 ]
    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.


Secondary Outcome Measures :
  1. The changes in nasal symptoms [ Time Frame: Baseline, week2, week4, week8, week12 ]
    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).

  2. Nasal patency [ Time Frame: Baseline, week4, week8 and week12 ]
    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) .

  3. Exhaled nasal nitric oxide [ Time Frame: Baseline, week4, week8 and week12 ]
    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.


Other Outcome Measures:
  1. 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. [ Time Frame: Baseline, week4, week8 and week12 ]
    The change of inflammatory cytokines (interleukin(IL)-4, IL-5, IL-8, IL-17, IL-22, IL-25, interferon-γ, tumor necrosis factor-α, transforming growth factor(TGF)-β1, TGF-β2, TGF-β3,Chemokine, Eotaxin) in nasal secretions as secondary outcomes. Nasal secretions were obtained by inserting a postoperative sinus pack in the nasal cavity (acupuncture side) for five minutes. The quantity of secretions was determined by comparing the weight of the sponges before and after insertion and 2 ml of 0.9% sodium chloride solution was added to each sponge. The sponges were stored at 4°C for two hours and the nasal secretions were recovered from the sponges by centrifugation at 1500 g for 15 minutes at 4°C. The supernatants were separated and stored in aliquots at -20°C until further analysis. The levels of inflammatory cytokines (pg/g) were analysed using the Luminex System.

  2. Mucosal pathology assessment [ Time Frame: Week4 ]
    We obtained nasal mucosa and performed pathological observations to observe changes in the level of inflammatory and changes in the number and quantity of inflammatory cells.

  3. Sinus CT scan [ Time Frame: Week 8 ]
    Using CT scanning, we observed changes in the Lund-Mackey scores of bilateral nasal sinuses .

  4. Changes in serum cortisol [ Time Frame: Baseline,week4 and week12 ]
    We validate the safety of stent implantation by examining serum cortisol.

  5. Adverse events [ Time Frame: Week2, week4, week8, week12 ]
    During the progress of the experiment, we pay attention to the findings of patients with or without severe reactions.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943121


Contacts
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Contact: kuiji Wang, doctor 861013811074506 wangkuiji123@126.com

Locations
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China, Beijing
Beijing Tongren Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Luo Zhang, M.D.    (86)13910830399    dr.luozhang@gmail.com   
Principal Investigator: Luo Zhang, M.D.         
Sponsors and Collaborators
Beijing Tongren Hospital
First Affiliated Hospital, Sun Yat-Sen University
China-Japan Union Hospital, Jilin University

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Responsible Party: Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT03943121    
Other Study ID Numbers: TR-Stent implant for CRSwNP
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Tongren Hospital:
Endoscopic sinus surgery
Eosinophilic sinusitis with nasal polyps
Steroid-eluting stent
Randomized Trial
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases