Steroid-Eluting Stent Implant for the Treatment of Radiation-Related Sinusitis

• Status: Recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Sinusitis is one of the most common sequelae after radiotherapy among nasopharyngeal carcinoma patients. While local steroids have been shown to be effective in the management of patients with chronic rhinosinusitis, their role in treating radiation-related sinusitis is ambiguous. Poor adherence to nasal steroid spray often contributes to the failure of symptom relief. The aim of this study is to determine if steroids stents implantation into the sinuses could improve patient outcomes in radiation-related sinusitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Fifth Affiliated Hospital of Guangzhou Medical University; Zhongshan People's Hospital, Guangdong, China

Criteria

Inclusion Criteria:

• pathologically confirmed nasopharyngeal carcinoma patients

• finished radical radiotherapy (≥66Gy) for at least 3 months

• tumor complete response

• received appropriate medical treatment for sinusitis during or after radiotherapy

• confirmed sinusitis according to European Position Paper on Rhinosinusitis and Nasal Polyps 2020

• SNOT-22 ≥ 20 and MRI Lund-Mackay score > 8

• 18-70 years old

Exclusion Criteria:

• anatomic variation resulted in occluded ostiomeatal complex

• Karnofsky score ≤ 70

• life-threatening medical conditions

• tumour residue or recurrence

• acute bacterial sinusitis or acute fungal sinusitis

• cystic fibrosis or primary ciliary dyskinesia

• dependence on prolonged corticosteroid therapy for comorbid conditions

• history of allergy to topical steroids

• pregnant or breastfeeding