Diagnostics of Mycotic Sinusitis in ENT Patients

Fungal Sinusitis Clinical Trial

Official title:

Diagnostics of Mycotic Sinusitis in Patients With Unilateral Obfuscation of the Paranasal Sinus and Patients With Uni-lateral Discharge From the Nasal Cavity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05955859
• Other study ID #: KORLCHHK-2023-Mycosis
• Secondary ID: 06-RVO-FNOs/2023
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: July 2023
• Source: University Hospital Ostrava
• Contact: Jirí Hyncica
• Phone: 0042059737
• Email: jiri.hyncica[@]fno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mycotic sinusitis is a rare inflammatory disease of the paranasal sinuses. In recent years, its occurrence is increasing. Due to this situation, mycotic sinusitis is gaining importance, even though most cases of mycotic sinusitis are limited on paranasal sinuses.

Non-invasive forms of mycotic sinusitis are divided into mycetoma and allergic mycotic sinusitis. Mycetoma (fungus ball) usually affects only one paranasal sinus, most often maxillary sinus. The predisposing factors which participate on development of mycotic sinusitis are not exactly known. Some factors are considered as possible predisposing factors, for example deviation of nasal septum, dental treatment of upper jaw teeth or changes of nasal microbiome.

The diagnosis of fungal sinusitis is problematic. With the increasing number of patients, it is essential to improve the diagnostic process. In present, suspicion of mycotic sinusitis is based on the patient's clinical symptoms and the endoscopic findings in the nasal cavity. Only in some cases nonspecific findings can be observed, such as smelly secretions from the nose, feeling of stuffy nose and pain over the affected sinus. Some patients may be completely asymptomatic, and only in some cases fungal masses can be observed in the nasal cavity. Computed tomography (CT) scans are gaining more and more importance. Typical sign of an affected sinus is obfuscation on CT scan but this sign is not specific for mycotic infection. Central hyperdense foci are also present in some patients, but they are also not specific and can imitate a foreign body. Identifying specific signs on CT scan could help with diagnosing mycotic sinusitis.

Description:

To identify specific determining signs for the diagnosis of fungal sinusitis, patients will undergo a series of examinations listed below.

1. Entrance ear, nose, throat (ENT) examination

• anamnesis (nasal secretion, nasal obstruction, nose injury, dental procedures on the teeth of the upper jaw, immune disorder)

• rhinological questionnaires (SNOT-22, rhinoVAS, NOSE score, olfactory questionnaire)

• ENT examination without endoscope: deviation of the nasal septum or hypertrophy of the nasal conchae, pathological secretion from the nose

• endoscopic examination of the nose: pathological secretion in the nasal cavity or from the orifice of the sinuses, the presence of fungal masses in the nasal cavity, obstruction of the orifice of the sinuses, the edge of the nasal septum

2. Computed tomography (CT) examination of the paranasal sinuses

• evaluation of images in the frontal, sagittal and transverse planes

• criteria of the affected cavity - complete/partial obscuration of the paranasal sinuses, hyperdense core, usuration or thickening of the bone of the paranasal sinuses

• anatomical conditions of the nose and paranasal sinuses - the presence of septal deviation, dental pathology, Onodi's cellar, Haller's cellar, lateral recess of the sphenoid sinus

3. Functional endonasal endoscopic surgery (FESS)

• method of execution performance of functional endonasal endoscopic surgery - only the affected cavity is being operated, complete cleaning of the affected cavity

• sampling during surgery (4 in total): two samples for histological examination (sample 1 - mycotic material, sample 2 - mucous of the affected paranasal sinus), sample 3 - mycotic material for culture examination of fungi, sample 4 - mycotic material for elemental analysis using electron microscopy .

4. postoperative sample analysis

• elemental analysis (sample 4): before analysis - control X-ray examination of the sample, the presence of hyperdense material on the X-ray image, performing electron microscopy, according to the structure of element evaluation.

• histological examination (sample 1 and 2): evaluation of the sample 2 - mucosa of the paranasal sinuses - the presence of fungal invasion into the mucosa, inflammatory cellulization in the mucosa, evaluation of the sample 1 (mycotic material) - the presence of hyphae, inflammatory cellulization, calcification.

• culture examination (sample 3): evaluation of the cultured finding by a microbiologist

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 31, 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• age = 18 years

• patients with unilateral obfuscation of the paranasal sinus and patients with unilateral discharge from the nasal cavity

Exclusion Criteria:

• serious illness (decompensation phase) - cardiac, liver, kidney disease, can-cer

• serious psychiatric illnesses

• pregnancy

• high operative risk according to The American Society of Anesthesiologists (ASA) = IV

• disagreement with participation in the study

Related Conditions & MeSH terms

• Fungal Sinusitis
• Sinusitis

Intervention

Procedure:
• Samplings from patient's affected paranasal sinus
Samplings from patient's affected paranasal sinus during endoscopic surgery.

Locations

Country	Name	City	State
Czechia	University Hospital Ostrava, Department of Otorhinolaryngology and Head and Neck Surgery	Ostrava	Czech Republic

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computer tomography (CT) examination of the paranasal sinuses - images	Evaluation of images in the frontal, sagittal and transverse planes - condition assessment.	3 years
Primary	Computer tomography (CT) examination of the paranasal sinuses - criteria	Evaluation of criteria of the affected cavity - complete/partial obscuration of the paranasal sinuses, hyperdense core, usuration or thickening of the bone of the paranasal sinuses.	3 years
Primary	Computer tomography (CT) examination of the paranasal sinuses - anatomical conditions of the nose and paranasal sinuses	Evaluation of anatomical conditions of the nose and paranasal sinuses - the presence of septal deviation, dental pathology, Onodi's cellar, Haller's cellar, lateral recess of the sphenoid sinus.	3 years
Primary	Entrance ENT examination - anamnesis	Taking anamnesis from patients to summarize any nasal secretion, nasal obstruction, nose injury, dental procedures on the teeth of the upper jaw or immune disorder.	3 years
Primary	Entrance ENT examination - SNOT-22	Sino-Nasal Outcome Test-22 (SNOT-22) Questionnaire - The patients will complete a list of symptoms and social/emotional consequences of their nasal disorder. The SNOT-22 is a validated scale that measures sinonasal symptoms in patients with sinusitis. The 22 questions are scored on a scale of 0-5 with a maximum total score of 110. Higher scores represent more symptomatic patients.	3 years
Primary	Entrance ENT examination - rhinoVAS	Rhino Visual Analogue Scale (RhinoVAS) questionnaire will be used to assess postoperative changes in nasal function ranging from 0 (complete nose patency) to 10 cm (complete nose obstruction).	3 years
Primary	Entrance ENT examination - NOSE score	A simple, five-question, validated Nasal Obstruction Symptom Evaluation (NOSE) instrument that uses a 20-point scale to capture breathing symptoms, with higher scores indicating more severe symptoms than lower scores. A score of 0 means no problems with nasal obstruction and a score of 100 means the worst possible problems with nasal obstruction.	3 years
Primary	Entrance ENT examination - olfactory questionnaire	Olfactory questionnaire includes a short examination (test of identification and discrimination with perfumed markers) will be performed.	3 years
Primary	Entrance ENT examination - without endoscope	Observation of deviation of the nasal septum or hypertrophy of the nasal concha, patho-logical secretion from the nose.	3 years
Primary	Entrance ENT examination - endoscopic examination	Endoscopic examination of the nose in order to find any pathological secretion in the nasal cavity or from the orifice of the sinuses, the presence of fungal masses in the nasal cavity, obstruction of the orifice of the sinuses, the edge of the nasal septum.	3 years
Primary	Functional endonasal endoscopic surgery (FESS) - sample 1	Mycotic material (as sample 1) for histological examination will be taken from patient´s affected cavity during FESS.	3 years
Primary	Functional endonasal endoscopic surgery (FESS) - sample 2	Mucous of the affected paranasal sinus (as sample 2) for histological examination will be taken from patient´s affected cavity during FESS.	3 years
Primary	Functional endonasal endoscopic surgery (FESS) - sample 3	Mycotic material for culture examination of fungi (as sample 3) will be taken from patient´s affected cavity during FESS.	3 years
Primary	Functional endonasal endoscopic surgery (FESS) - sample 4	Mycotic material for elemental analysis using electron microscopy (as sample 4) will be taken from patient´s affected cavity during FESS.	3 years
Primary	Postoperative sample analysis - histological examination of sample 1	Evaluation of the sample 1 (mycotic material) will be done to find out the presence of hyphae, inflammatory cellulization, calcification.	3 years
Primary	Postoperative sample analysis - histological examination of sample 2	Evaluation of the sample 2 (mucosa of the paranasal sinuses) will be done to find out the presence of fungal invasion into the mucosa, inflammatory cellulization in the mucosa.	3 years
Primary	Postoperative sample analysis - culture examination of sample 3	Evaluation of the cultured finding will be done by a microbiologist.	3 years
Primary	Postoperative sample analysis - elemental analysis of sample 4	Control X-ray examination of the sample will be taken before analysis to find out the presence of hyperdense material on the X-ray image. Performing electron microscopy, according to the structure of ele-ment evaluation.	3 years