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Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP
Sponsor: Eye & ENT Hospital of Fudan University
Summary
This study compares two surgical approaches combined with anti-IL-5 therapy in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). Patients will be randomly assigned to one of the three groups: (1) anti-IL-5 alone, (2) anti-IL-5 with simple polyp removal, or (3) anti-IL-5 with extended sinus surgery. The aim of this study is to see if a less invasive surgery (simple polyp removal) with anti-IL-5 works as well as more extensive surgery with anti-IL-5. Participants will be followed for 1 to 3 years.
Official title: Efficacy of Anti-IL-5 Therapy Combined With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery in Patients With CRSwNP: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2025-10-08
Completion Date
2031-10-10
Last Updated
2025-10-01
Healthy Volunteers
No
Interventions
Mepolizumab
Subcutaneous injection of mepolizumab is administered every 4 weeks for a total treatment duration of 24 weeks.
Simple Polypectomy
Removal of nasal polyps in the middle meatus and superior turbinate region via the middle meatus and olfactory cleft, without opening the involved sinuses and without resection of diseased bone.
Extended Endoscopic Sinus Surgery
1. Complete opening of all sinuses 2. Resection of diseased mucosa and hyperplastic bone 3. Ethmoid skeletonization with middle turbinectomy 4. Draf IIb/III frontal dissection when indicated by CT severity.
Locations (17)
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Longgang District Central Hospital of Shenzhen
Shenzhen, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin hospital of Wuhan University
Wuhan, Hubei, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
The Affiliated Hospital of Yunnan University
Kunming, Yunnan, China
Affiliated Hangzhou First People's Hospital,School of Medicine, Westlake University
Hangzhou, Zhejiang, China