Clinical trial NCT05955859: Diagnostics of Mycotic Sinusitis in ENT Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fungal Sinusitis
Keywords: Sinusitis
Mycosis
Paranasal sinus
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Computer tomography (CT) examination of the paranasal sinuses - images
timeFrame: 3 years
measure: Computer tomography (CT) examination of the paranasal sinuses - criteria
timeFrame: 3 years
measure: Computer tomography (CT) examination of the paranasal sinuses - anatomical conditions of the nose and paranasal sinuses
timeFrame: 3 years
measure: Entrance ENT examination - anamnesis
timeFrame: 3 years
measure: Entrance ENT examination - SNOT-22
timeFrame: 3 years
measure: Entrance ENT examination - rhinoVAS
timeFrame: 3 years
measure: Entrance ENT examination - NOSE score
timeFrame: 3 years
measure: Entrance ENT examination - olfactory questionnaire
timeFrame: 3 years
measure: Entrance ENT examination - without endoscope
timeFrame: 3 years
measure: Entrance ENT examination - endoscopic examination
timeFrame: 3 years
measure: Functional endonasal endoscopic surgery (FESS) - sample 1
timeFrame: 3 years
measure: Functional endonasal endoscopic surgery (FESS) - sample 2
timeFrame: 3 years
measure: Functional endonasal endoscopic surgery (FESS) - sample 3
timeFrame: 3 years
measure: Functional endonasal endoscopic surgery (FESS) - sample 4
timeFrame: 3 years
measure: Postoperative sample analysis - histological examination of sample 1
timeFrame: 3 years
measure: Postoperative sample analysis - histological examination of sample 2
timeFrame: 3 years
measure: Postoperative sample analysis - culture examination of sample 3
timeFrame: 3 years
measure: Postoperative sample analysis - elemental analysis of sample 4
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava, Department of Otorhinolaryngology and Head and Neck Surgery
state: Czech Republic
Study officials:
affiliation: University Hospital Ostrava
name: Simona Polášková, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Ostrava
name: Petr Matoušek, MD, Ph.D.
role: STUDY_CHAIR
affiliation: University Hospital Ostrava
name: Michaela Masárová, MD
role: STUDY_CHAIR
affiliation: University Hospital Ostrava
name: Pavel Komínek, Prof., MD, Ph.D.
role: STUDY_CHAIR
References: