Chronic SinusitisNCT07073664
A Study Evaluating the Efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) Combined With Stapokibart in the Treatment of Type 2 Chronic Rhinosinusitis
A study testing The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) and The surgical side of Endoscopic Sinus Surgery (ESS) in people with Chronic Sinusitis, run by China-Japan Union Hospital at 1 site in China.
Trial summary
Through a prospective study, the efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) in the surgical treatment of patients with type 2 chronic rhinosinusitis was verified. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) and The surgical side of Endoscopic Sinus Surgery (ESS)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnostic criteria for chronic rhinosinusitis refer to "Chinese Guidelines for Diagnosis and Treatment of Chronic Rhinosinusitis (2024)", namely: (1) Symptoms: nasal congestion, nasal discharge; secondary symptoms: headache in the head and face, reduced or lost sense of smell. (2) Endoscopic examination: bilateral lesions, mucous or mucopurulent secretions from the middle meatus and choana, nasal mucosa congestion, edema or polyps. The difference in endoscopic scores between both sides is no more than 2. (3) Imaging examination: bilateral lesions, nasal sinus CT scan can show the ostiomeatal complex and/or inflammatory lesions of the nasal sinus mucosa. The difference in CT scores between both sides is no more than 2.
- Diagnostic criteria for type 2 chronic rhinosinusitis refer to "2023 EPOS on the indications for biological therapy of CRSwNP", namely: (1) Evidence of type 2 inflammation: eosinophils (EOS) >=10/hpf in tissue, or EOS>=150 in blood, or total IgE >=100; (2) Need for systemic glucocorticoids or contraindications to systemic glucocorticoids: >= 2 courses per year, or long-term (> 3 months) low-dose glucocorticoids; (3) Significant impairment of quality of life: SNOT-22 >= 40; (4) Obvious loss of sense of smell: loss of sense of smell in the smell test; (5) Diagnosis of combined asthma: asthma requiring regular inhalation of glucocorticoids. Three of the five conditions can diagnose type 2 inflammation.
- History of rhinosinusitis for more than 2 years, patients enrolled in China-Japan Union Hospital of Jilin University whose residence is in Northeast China meet the requirements for postoperative follow-up (including Heilongjiang Province, Jilin Province, Liaoning Province, and Hulunbuir City, Xing'an League, Tongliao City, Chifeng City, and Xilingol League of Inner Mongolia Autonomous Region). Patients enrolled in the First Affiliated Hospital of Jinan University whose residence is in southern China meet the requirements for postoperative follow-up (including Guangdong Province and Guangxi Zhuang Autonomous Region).
Who cannot join
- Pregnant women.
- Patients with diabetes, hypertension, coronary heart disease, tuberculosis, asthma, and malignant tumors who cannot tolerate general anesthesia surgery.
- Other patients who are unable to receive or unwilling to undergo surgical treatment due to severe systemic diseases or mental disorders.
- Patients who are unable to cooperate with postoperative follow-up.
- Age < 18 years old or > 75 years old.
- Patients who have received allergen-specific immunotherapy or biological agent treatment within the past year.
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- Patients with a history of sinus surgery in the past.
- Those with acute infectious diseases, upper respiratory tract infections or systemic inflammatory symptoms such as fever and chills.
- Those who cannot tolerate severe systemic or local adverse reactions during relevant examinations or specimen collection.
- Patients whom the researchers consider ineligible for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
About this study
Official title: A Prospective, Randomized, Single-blind, Self-controlled Study Evaluating the Efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) Combined With Stapokibart in the Treatment of Type 2 Chronic Rhinosinusitis
Through a prospective study, the efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) in the surgical treatment of patients with type 2 chronic rhinosinusitis was verified. The aim was to provide evidence-based medical evidence for the effectiveness of local minimally invasive surgery combined with biologics in the treatment of type 2 chronic rhinosinusitis.
- Conditions
- Chronic Sinusitis
- Being tested
- The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES), The surgical side of Endoscopic Sinus Surgery (ESS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES)Procedure or surgery
Surgery was performed by Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) . Stapokibart from two weeks after the operation, subcutaneous injection of Stapokibart was administered once every two weeks for six consecutive months, a total of 12 times.
The surgical side of Endoscopic Sinus Surgery (ESS)Procedure or surgery
Description: Surgery was performed by Endoscopic Sinus Surgery (ESS). Stapokibart from two weeks after the operation, subcutaneous injection of Stapokibart was administered once every two weeks for six consecutive months, a total of 12 times.
| Study group | Role | What they receive |
|---|---|---|
| The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) | Experimental | Not described Receives: Procedure: The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) |
| The surgical side of Endoscopic Sinus Surgery (ESS) | Active comparator | Not described Receives: Procedure: The surgical side of Endoscopic Sinus Surgery (ESS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale(VAS) score of nasal symptoms
The minimum possible scale value is 0, and the maximum possible scale value is 10. The higher scores mean a worse outcome.
Measured: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Nasal endoscopy score(Lund-Kennedy scores, LKs)
The minimum possible scale value is 0, and the maximum possible scale value is 10. The higher scores mean a worse outcome.
Measured: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Paranasal sinus CT score(Lund-Mackey scores, LMs)
The minimum possible scale value is 0, and the maximum possible scale value is 12. The higher scores mean a worse outcome.
Measured: 6 months and 12 months after surgery.
Nasal polyps scores(NPs)
The minimum possible scale value is 0, and the maximum possible scale value is 4. The higher scores mean a worse outcome.
Measured: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Questionnaire score for Sinusitis Quality of Life(SNOT-22 scores)
The minimum possible scale value is 0, and the maximum possible scale value is 110. The higher scores mean a worse outcome.
Measured: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Secondary outcomes (1)
Life quality score(SF-36 scores)
The minimum possible scale value is 0, and the maximum possible scale value is 100. The higher scores mean a better outcome.
Measured: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start21 Apr 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongdong Zhu, China-Japan Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073664
- Sponsor's protocol ID
- 2025041701
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-blind, Self-controlled Study Evaluating the Efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) Combined With Stapokibart in the Treatment of Type 2 Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT07073664
- Acronym / sponsor ID
- 2025041701
- Conditions
- Chronic Sinusitis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China-Japan Union HospitalUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through a prospective study, the efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) in the surgical treatment of patients with type 2 chronic rhinosinusitis was verified. The aim was to provide evidence-based medical evidence for the effectiveness of local minimally invasive surgery combined with biologics in the treatment of type 2 chronic rhinosinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) | Experimental | Procedure: The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) |
| The surgical side of Endoscopic Sinus Surgery (ESS) | Active comparator | Procedure: The surgical side of Endoscopic Sinus Surgery (ESS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnostic criteria for chronic rhinosinusitis refer to "Chinese Guidelines for Diagnosis and Treatment of Chronic Rhinosinusitis (2024)", namely: (1) Symptoms: nasal congestion, nasal discharge; secondary symptoms: headache in the head and face, reduced or lost sense of smell. (2) Endoscopic examination: bilateral lesions, mucous or mucopurulent secretions from the middle meatus and choana, nasal mucosa congestion, edema or polyps. The difference in endoscopic scores between both sides is no more than 2. (3) Imaging examination: bilateral lesions, nasal sinus CT scan can show the ostiomeatal complex and/or inflammatory lesions of the nasal sinus mucosa. The difference in CT scores between both sides is no more than 2.
- Diagnostic criteria for type 2 chronic rhinosinusitis refer to "2023 EPOS on the indications for biological therapy of CRSwNP", namely: (1) Evidence of type 2 inflammation: eosinophils (EOS) >=10/hpf in tissue, or EOS>=150 in blood, or total IgE >=100; (2) Need for systemic glucocorticoids or contraindications to systemic glucocorticoids: >= 2 courses per year, or long-term (> 3 months) low-dose glucocorticoids; (3) Significant impairment of quality of life: SNOT-22 >= 40; (4) Obvious loss of sense of smell: loss of sense of smell in the smell test; (5) Diagnosis of combined asthma: asthma requiring regular inhalation of glucocorticoids. Three of the five conditions can diagnose type 2 inflammation.
- History of rhinosinusitis for more than 2 years, patients enrolled in China-Japan Union Hospital of Jilin University whose residence is in Northeast China meet the requirements for postoperative follow-up (including Heilongjiang Province, Jilin Province, Liaoning Province, and Hulunbuir City, Xing'an League, Tongliao City, Chifeng City, and Xilingol League of Inner Mongolia Autonomous Region). Patients enrolled in the First Affiliated Hospital of Jinan University whose residence is in southern China meet the requirements for postoperative follow-up (including Guangdong Province and Guangxi Zhuang Autonomous Region).
Key exclusion criteria (10 listed)
- Pregnant women.
- Patients with diabetes, hypertension, coronary heart disease, tuberculosis, asthma, and malignant tumors who cannot tolerate general anesthesia surgery.
- Other patients who are unable to receive or unwilling to undergo surgical treatment due to severe systemic diseases or mental disorders.
- Patients who are unable to cooperate with postoperative follow-up.
- Age < 18 years old or > 75 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES)Surgery was performed by Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) . Stapokibart from two weeks after the operation, subcutaneous injection of Stapokibart was administered once every two weeks for six consecutive months, a total of 12 times. | Procedure or surgery | The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) |
| The surgical side of Endoscopic Sinus Surgery (ESS)Description: Surgery was performed by Endoscopic Sinus Surgery (ESS). Stapokibart from two weeks after the operation, subcutaneous injection of Stapokibart was administered once every two weeks for six consecutive months, a total of 12 times. | Procedure or surgery | The surgical side of Endoscopic Sinus Surgery (ESS) |
Primary outcome
Visual analogue scale(VAS) score of nasal symptoms
Time frame: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 10. The higher scores mean a worse outcome.
Nasal endoscopy score(Lund-Kennedy scores, LKs)
Time frame: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 10. The higher scores mean a worse outcome.
Paranasal sinus CT score(Lund-Mackey scores, LMs)
Time frame: 6 months and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 12. The higher scores mean a worse outcome.
Nasal polyps scores(NPs)
Time frame: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 4. The higher scores mean a worse outcome.
Questionnaire score for Sinusitis Quality of Life(SNOT-22 scores)
Time frame: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
The minimum possible scale value is 0, and the maximum possible scale value is 110. The higher scores mean a worse outcome.
1 secondary outcome
Life quality score(SF-36 scores)
Time frame: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) and The surgical side of Endoscopic Sinus Surgery (ESS) in people with Chronic Sinusitis, run by China-Japan Union Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale(VAS) score of nasal symptoms (time frame: Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.