Research on Identifying and Treatment Prognosis of Chronic Rhinosinusitis Based on Image and Sequencing Data

NCT05983003 | Completed DMC

• 1 other identifier: ENT-Radiology-01
• Study Type: observational
• Target: 3,500
• Locations: 1 country
• Sites: 1

Brief Summary

This project focuses on researching chronic rhinosinusitis in patients, employing image processing techniques and molecular biology methods to jointly determine the research objectives:

1. 1.Investigating heterogeneity.
2. 2.Developing an intelligent assessment model.
3. 3.Creating a visual tool for diagnosis and prognosis.

Conditions

Chronic Sinusitis; Radiology; Pathology; Surgery; Progression

Keywords

Chronic Sinusitis; Radiology; Progression

Outcome Measures

Primary Outcomes (1)

• Change from baseline at months 12 in visual analogue scale (VAS) after surgical intervention

  The VAS for rhinosinusitis was used to evaluate the total disease severity. The participants were asked to indicate on a 10 centimeters (cm) VAS the answer to the question, "How troublesome are your symptoms of your rhinosinusitis?" The range of the VAS was from 0 (not troublesome) to 10 (worse thinkable troublesome) of troublesome, where higher score indicated worse thinkable troublesome.

  12month

Secondary Outcomes (5)

• Change from baseline at months 1, 3, 6 and 12 in 22-item sino-nasaloutcome test (SNOT-22) scores after surgical intervention

  1month, 3month, 6month, 12month

• Revision surgery rate

  12month

• Symptom duration

  1month, 3month, 6month, 12month

• Change from baseline at months 1, 3, 6 and 12 in nasal endoscopic score after surgical intervention

  1month, 3month, 6month, 12month

• Postoperative medication

  1month, 3month, 6month, 12month

Other Outcomes (2)

• Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid by Bio-plex

  1month, 3month, 6month, 12month

• Changes from baseline at months 1, 3, 6 and 12 in molecular indices of nasal lavage fluid by ELISA

  1month, 3month, 6month, 12month

Study Arms (2)

Control

Following the efficacy assessment method outlined in the 2020 EPOS guidelines, the treatment outcomes of chronic sinusitis are categorized as "controlled" or "uncontrolled." Clinical reference evaluation criteria include: nasal congestion, rhinorrhea, facial pain, reduced sense of smell, sleep disturbances, the need for ongoing medication maintenance and the abnormal nasal endoscopy findings, .If there are no three or more symptoms rated five or higher, the patient's chronic sinusitis is considered controlled.

Procedure: endoscopic sinus surgery

Uncontrol

Following the efficacy assessment method outlined in the 2020 EPOS guidelines, the treatment outcomes of chronic sinusitis are categorized as "controlled" or "uncontrolled." Clinical reference evaluation criteria include: nasal congestion, rhinorrhea, facial pain, reduced sense of smell, sleep disturbances, the need for ongoing medication maintenance and the abnormal nasal endoscopy findings, . The classification is based on the number and severity of these symptoms,and patients with three or more symptoms rated five or higher are considered to have uncontrolled disease

Procedure: endoscopic sinus surgery

Interventions

endoscopic sinus surgery PROCEDURE

Open the sinus ostium, improve anatomical issues and remove the diseased tissue.

Also known as: ESS

Control; Uncontrol

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic rhinosinusitis (CRS) was diagnosed according to the international guideline European position paper on rhinosinusitis and nasal polyps (EPOS) 2020. All the patients had ongoing symptoms after initial attempts on medical treatments and underwent endoscopic sinus surgery.

You may qualify if:

• oral glucocorticoid, and intranasal steroid spray and steroid irrigation treatment were discontinued at least 3 months and 1 month before surgery, respectively;
• without acute asthma episode or acute upper airway infection within 1 month before surgery;
• not under allergen immunotherapy or biologic treatment.

You may not qualify if:

• fungal sinusitis;
• antrochoanal polyps;
• cystic fibrosis, vasculitis, primary ciliary dyskinesia, or immunodeficiency;
• odontogenic maxillary sinusitis;
• patients with history of craniocerebral trauma or sinonasal tumours.
• insufficient CT quality (e.g., metal artifacts, motion artifacts, and lack of intact CT scan of sinuses);
• slice thickness more than 2.5 mm.
• women must not be pregnant, or breast-feeding;
• patients with serious metabolic, cardiovascular, autoimmune, neurology, blood, digestive, cerebrovascular, or respiratory system disease, or any disease interfering with the evaluation of results or affecting subjects safety are excluded, such as glaucoma and tuberculosis;
• patients with emotional or mental problems are excluded;

Sponsors & Collaborators

• Zheng Liu: lead
• Wuhan Central Hospital: collaborator
• First Affiliated Hospital of Zhongshan Medical University: collaborator
• Clifford Hospital, Guangzhou, China: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Shanxi Bethune Hospital: collaborator
• The First Affiliated Hospital of Nanchang University: collaborator
• Xiangyang Central Hospital: collaborator
• Longgang District People's Hospital of Shenzhen: collaborator
• Wuhan Integrated Traditional Chinese and Western Medicine Hospital: collaborator
• Wuhan Third Hospital: collaborator
• Yangxin Hospital: collaborator

Study Sites (1)

Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Related Publications (2)

• Fokkens WJ, Lund VJ, Hopkins C, Hellings PW, Kern R, Reitsma S, Toppila-Salmi S, Bernal-Sprekelsen M, Mullol J, Alobid I, Terezinha Anselmo-Lima W, Bachert C, Baroody F, von Buchwald C, Cervin A, Cohen N, Constantinidis J, De Gabory L, Desrosiers M, Diamant Z, Douglas RG, Gevaert PH, Hafner A, Harvey RJ, Joos GF, Kalogjera L, Knill A, Kocks JH, Landis BN, Limpens J, Lebeer S, Lourenco O, Meco C, Matricardi PM, O'Mahony L, Philpott CM, Ryan D, Schlosser R, Senior B, Smith TL, Teeling T, Tomazic PV, Wang DY, Wang D, Zhang L, Agius AM, Ahlstrom-Emanuelsson C, Alabri R, Albu S, Alhabash S, Aleksic A, Aloulah M, Al-Qudah M, Alsaleh S, Baban MA, Baudoin T, Balvers T, Battaglia P, Bedoya JD, Beule A, Bofares KM, Braverman I, Brozek-Madry E, Richard B, Callejas C, Carrie S, Caulley L, Chussi D, de Corso E, Coste A, El Hadi U, Elfarouk A, Eloy PH, Farrokhi S, Felisati G, Ferrari MD, Fishchuk R, Grayson W, Goncalves PM, Grdinic B, Grgic V, Hamizan AW, Heinichen JV, Husain S, Ping TI, Ivaska J, Jakimovska F, Jovancevic L, Kakande E, Kamel R, Karpischenko S, Kariyawasam HH, Kawauchi H, Kjeldsen A, Klimek L, Krzeski A, Kopacheva Barsova G, Kim SW, Lal D, Letort JJ, Lopatin A, Mahdjoubi A, Mesbahi A, Netkovski J, Nyenbue Tshipukane D, Obando-Valverde A, Okano M, Onerci M, Ong YK, Orlandi R, Otori N, Ouennoughy K, Ozkan M, Peric A, Plzak J, Prokopakis E, Prepageran N, Psaltis A, Pugin B, Raftopulos M, Rombaux P, Riechelmann H, Sahtout S, Sarafoleanu CC, Searyoh K, Rhee CS, Shi J, Shkoukani M, Shukuryan AK, Sicak M, Smyth D, Sindvongs K, Soklic Kosak T, Stjarne P, Sutikno B, Steinsvag S, Tantilipikorn P, Thanaviratananich S, Tran T, Urbancic J, Valiulius A, Vasquez de Aparicio C, Vicheva D, Virkkula PM, Vicente G, Voegels R, Wagenmann MM, Wardani RS, Welge-Lussen A, Witterick I, Wright E, Zabolotniy D, Zsolt B, Zwetsloot CP. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology. 2020 Feb 20;58(Suppl S29):1-464. doi: 10.4193/Rhin20.600.

  PMID: 32077450 RESULT

• Hu Y, Cao PP, Liang GT, Cui YH, Liu Z. Diagnostic significance of blood eosinophil count in eosinophilic chronic rhinosinusitis with nasal polyps in Chinese adults. Laryngoscope. 2012 Mar;122(3):498-503. doi: 10.1002/lary.22507. Epub 2012 Jan 17.

  PMID: 22252861 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

For patients with chronic sinusitis undergoing surgical treatment, nasal polyps or ethmoid sinus lesion mucosa will be collected during the operation. For the control group, mucosa will be taken from patients undergoing surgery for nasal septum deviation or nasal sinus trauma, and normal ethmoid sinus mucosa or inferior turbinate tissue will be collected during the operation. The collected tissue specimens will be divided into two parts, with one part being fixed in 4% paraformaldehyde and the other part stored at -80°C.

MeSH Terms

Conditions

Disease Progression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zheng Liu, Doctor

  Huazhong University of Science and Techology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Otolaryngology-Head & Neck Surgery Vice Director Department of ENT Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Affiliation: Huazhong University of Science and Technology

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 9, 2023
• Study Start: March 1, 2015
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)