A Study Evaluating the Efficacy of Endoscope Ethmoid Infu... | NCT07073664

NCT07073664

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The surgical side of Endoscope Ethmoid Infundibulum Expansion Surgery (EEIES)	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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.	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.	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.	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.	Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.

Secondary Outcomes

Measure	Description	Time Frame
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.	Two weeks, 1 month, 3 months, 6 months, and 12 months after surgery.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.
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.