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

NCT ID: NCT03943121

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2021-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Steroid-eluting stent implant

Intervention Type: PROCEDURE

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

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.

Group Type: SHAM_COMPARATOR

Without Steroid-eluting stent implant

Intervention Type: 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.

Interventions

Steroid-eluting stent implant

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

Intervention Type: 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.

Intervention Type: PROCEDURE

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

China-Japan Union Hospital, Jilin University

OTHER

Sponsor Role: collaborator

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

TR-Stent implant for CRSwNP

Identifier Type: -

Identifier Source: org_study_id