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

NCT03943121 | Unknown DMC

• 1 other identifier: TR-Stent implant for CRSwNP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Patients; Sinusitis; Nasal Polyps

Keywords

Endoscopic sinus surgery; Eosinophilic sinusitis with nasal polyps; Steroid-eluting stent; Randomized Trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The changes in nasal symptoms

  Baseline, week2, week4, week8, week12

• Nasal patency

  Baseline, week4, week8 and week12

• Exhaled nasal nitric oxide

  Baseline, week4, week8 and week12

Other Outcomes (5)

• 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.

  Baseline, week4, week8 and week12

• Mucosal pathology assessment

  Week4

• Sinus CT scan

  Week 8

Study Arms (2)

Steroid-eluting stent implant

EXPERIMENTAL

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

Without Steroid-eluting stent implant

SHAM COMPARATOR

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

Interventions

Steroid-eluting stent implant PROCEDURE

After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus.

Steroid-eluting stent implant

Without Steroid-eluting stent implant PROCEDURE

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.

Without Steroid-eluting stent implant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• China-Japan Union Hospital, Jilin University: collaborator

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Sinusitis; Nasal Polyps

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 9, 2019
• Study Start: October 8, 2018
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-01

Locations

CN (1)