A Study Evaluating the Efficacy of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES) Combined With Stapokibart in the Treatment of Type 2 Chronic Rhinosinusitis
NCT ID: NCT07073664
Last Updated: 2025-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
30 participants
INTERVENTIONAL
2025-04-21
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES)
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.
The surgical side of Endoscopic Sinus Surgery (ESS)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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.
3. 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).
Exclusion Criteria
2. Patients with diabetes, hypertension, coronary heart disease, tuberculosis, asthma, and malignant tumors who cannot tolerate general anesthesia surgery.
3. Other patients who are unable to receive or unwilling to undergo surgical treatment due to severe systemic diseases or mental disorders.
4. Patients who are unable to cooperate with postoperative follow-up.
5. Age \< 18 years old or \> 75 years old.
6. Patients who have received allergen-specific immunotherapy or biological agent treatment within the past year.
7. Patients with a history of sinus surgery in the past.
8. Those with acute infectious diseases, upper respiratory tract infections or systemic inflammatory symptoms such as fever and chills.
9. Those who cannot tolerate severe systemic or local adverse reactions during relevant examinations or specimen collection.
10. Patients whom the researchers consider ineligible for enrollment.
18 Years
75 Years
ALL
No
Sponsors
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China-Japan Union Hospital
OTHER
Responsible Party
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Dongdong Zhu
Department Director
Locations
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China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Countries
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Other Identifiers
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2025041701
Identifier Type: -
Identifier Source: org_study_id
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