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

Primary Purpose

Patients, Sinusitis, Nasal Polyps

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Steroid-eluting stent implant

Without Steroid-eluting stent implant

About this trial

This is an interventional treatment trial for Patients focused on measuring Endoscopic sinus surgery, Eosinophilic sinusitis with nasal polyps, Steroid-eluting stent, Randomized Trial

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;

Sites / Locations

Beijing Tongren Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Steroid-eluting stent implant

Without Steroid-eluting stent implant

Arm Description

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.

The ESS procedure had to be successfully completed without complication on both sides. The side without the stent is defined as the control side.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The changes in nasal symptoms

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

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

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.

Full Information

NCT ID

NCT03943121

First Posted

May 4, 2019

Last Updated

June 16, 2021

Sponsor

Beijing Tongren Hospital

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, China-Japan Union Hospital, Jilin University

1. Study Identification

Unique Protocol Identification Number

NCT03943121

Brief Title

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

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 8, 2018 (Actual)

Primary Completion Date

September 1, 2021 (Anticipated)

Study Completion Date

October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Tongren Hospital

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, China-Japan Union Hospital, Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patients, Sinusitis, Nasal Polyps

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Steroid-eluting stent implant

Arm Type

Experimental

Arm Description

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.

Arm Title

Without Steroid-eluting stent implant

Arm Type

Sham Comparator

Arm Description

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 Type

Procedure

Intervention Name(s)

Steroid-eluting stent implant

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Without Steroid-eluting stent implant

Intervention Description

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 Measure Information:

Title

The change in the Lund-Kennedy endoscopic score

Description

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.

Time Frame

Baseline, week4,week 8 and week 12

Secondary Outcome Measure Information:

Title

The changes in nasal symptoms

Description

Time Frame

Baseline, week2, week4, week8, week12

Title

Nasal patency

Description

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) .

Time Frame

Baseline, week4, week8 and week12

Title

Exhaled nasal nitric oxide

Description

Time Frame

Baseline, week4, week8 and week12

Other Pre-specified Outcome Measures:

Title

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.

Description

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.

Time Frame

Baseline, week4, week8 and week12

Title

Mucosal pathology assessment

Description

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.

Time Frame

Week4

Title

Sinus CT scan

Description

Using CT scanning, we observed changes in the Lund-Mackey scores of bilateral nasal sinuses .

Time Frame

Week 8

Title

Changes in serum cortisol

Description

We validate the safety of stent implantation by examining serum cortisol.

Time Frame

Baseline,week4 and week12

Title

Adverse events

Description

During the progress of the experiment, we pay attention to the findings of patients with or without severe reactions.

Time Frame

Week2, week4, week8, week12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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;

Facility Information:

Facility Name

Beijing Tongren Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

12. IPD Sharing Statement

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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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