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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

Tracking Information
First Submitted Date  ICMJE May 4, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date June 4, 2019
Actual Study Start Date  ICMJE October 8, 2018
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • 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).
  • 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) .
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 7, 2019)
  • 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.
  • 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.
  • Sinus CT scan [ Time Frame: Week 8 ]
    Using CT scanning, we observed changes in the Lund-Mackey scores of bilateral nasal sinuses .
  • Changes in serum cortisol [ Time Frame: Baseline,week4 and week12 ]
    We validate the safety of stent implantation by examining serum cortisol.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
Official Title  ICMJE The Effects of Steroid-eluting Stent Implant for the Treatment of Patients Undergoing Sinus Surgery for Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Patients
  • Sinusitis
  • Nasal Polyps
Intervention  ICMJE
  • Procedure: Steroid-eluting stent implant
    After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Steroid-eluting stent implant
  • 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.
    Intervention: Procedure: Without Steroid-eluting stent implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: kuiji Wang, doctor 861013811074506 wangkuiji123@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03943121
Other Study ID Numbers  ICMJE TR-Stent implant for CRSwNP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beijing Tongren Hospital
Study Sponsor  ICMJE Beijing Tongren Hospital
Collaborators  ICMJE
  • First Affiliated Hospital, Sun Yat-Sen University
  • China-Japan Union Hospital, Jilin University
Investigators  ICMJE Not Provided
PRS Account Beijing Tongren Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP