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

June 16, 2021 updated by: Beijing Tongren Hospital

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Beijing Tongren Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week4,week 8 and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, week2, week4, week8, week12
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) .
Baseline, week4, week8 and week12
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.
Baseline, week4, week8 and week12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week4, week8 and week12
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.
Week4
Sinus CT scan
Time Frame: Week 8
Using CT scanning, we observed changes in the Lund-Mackey scores of bilateral nasal sinuses .
Week 8
Changes in serum cortisol
Time Frame: Baseline,week4 and week12
We validate the safety of stent implantation by examining serum cortisol.
Baseline,week4 and week12
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.
Week2, week4, week8, week12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2018

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

May 4, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR-Stent implant for CRSwNP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sinusitis

Clinical Trials on Steroid-eluting stent implant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe