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NCT Number: NCT05955859

Diagnostics of Mycotic Sinusitis in ENT Patients

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.

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Key information

Conditions

Fungal Sinusitis Bacterial Infections and Mycoses Infections Mycoses Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Sinusitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ostrava, Department of Otorhinolaryngology and Head and Neck Surgery

Ostrava, Czech Republic, 70852, Czechia

Location status: Recruiting

Location contact

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Simona Polášková, MD

PRINCIPAL_INVESTIGATOR

About this study

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

  • 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
  • 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
  • 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 .
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samplings from patient's affected paranasal sinus

Procedure

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

Primary outcomes

  1. Computer tomography (CT) examination of the paranasal sinuses - images

    Time frame: 3 years

    Evaluation of images in the frontal, sagittal and transverse planes - condition assessment.

  2. Computer tomography (CT) examination of the paranasal sinuses - criteria

    Time frame: 3 years

    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. Computer tomography (CT) examination of the paranasal sinuses - anatomical conditions of the nose and paranasal sinuses

    Time frame: 3 years

    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.

  4. Entrance ENT examination - anamnesis

    Time frame: 3 years

    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.

  5. Entrance ENT examination - SNOT-22

    Time frame: 3 years

    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.

  6. Entrance ENT examination - rhinoVAS

    Time frame: 3 years

    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).

  7. Entrance ENT examination - NOSE score

    Time frame: 3 years

    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.

  8. Entrance ENT examination - olfactory questionnaire

    Time frame: 3 years

    Olfactory questionnaire includes a short examination (test of identification and discrimination with perfumed markers) will be performed.

  9. Entrance ENT examination - without endoscope

    Time frame: 3 years

    Observation of deviation of the nasal septum or hypertrophy of the nasal concha, patho-logical secretion from the nose.

  10. Entrance ENT examination - endoscopic examination

    Time frame: 3 years

    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.

  11. Functional endonasal endoscopic surgery (FESS) - sample 1

    Time frame: 3 years

    Mycotic material (as sample 1) for histological examination will be taken from patient´s affected cavity during FESS.

  12. Functional endonasal endoscopic surgery (FESS) - sample 2

    Time frame: 3 years

    Mucous of the affected paranasal sinus (as sample 2) for histological examination will be taken from patient´s affected cavity during FESS.

  13. Functional endonasal endoscopic surgery (FESS) - sample 3

    Time frame: 3 years

    Mycotic material for culture examination of fungi (as sample 3) will be taken from patient´s affected cavity during FESS.

  14. Functional endonasal endoscopic surgery (FESS) - sample 4

    Time frame: 3 years

    Mycotic material for elemental analysis using electron microscopy (as sample 4) will be taken from patient´s affected cavity during FESS.

  15. Postoperative sample analysis - histological examination of sample 1

    Time frame: 3 years

    Evaluation of the sample 1 (mycotic material) will be done to find out the presence of hyphae, inflammatory cellulization, calcification.

  16. Postoperative sample analysis - histological examination of sample 2

    Time frame: 3 years

    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.

  17. Postoperative sample analysis - culture examination of sample 3

    Time frame: 3 years

    Evaluation of the cultured finding will be done by a microbiologist.

  18. Postoperative sample analysis - elemental analysis of sample 4

    Time frame: 3 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 21, 2023
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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