Diagnostics of Mycotic Sinusitis in ENT Patients

NCT ID: NCT05955859

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-02
• Study Completion Date: 2026-12-31

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

Conditions

Fungal Sinusitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient with clinical suspicion of mycotic sinusitis

Patient with clinical suspicion of mycotic sinusitis will undergo an examination as listed in Detailed Description.

Group Type: EXPERIMENTAL

Samplings from patient's affected paranasal sinus

Intervention Type: PROCEDURE

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

Interventions

Samplings from patient's affected paranasal sinus

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simona Polášková, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Ostrava

Petr Matoušek, MD, Ph.D.

Role: STUDY_CHAIR

University Hospital Ostrava

Michaela Masárová, MD

Role: STUDY_CHAIR

University Hospital Ostrava

Pavel Komínek, Prof., MD, Ph.D.

Role: STUDY_CHAIR

University Hospital Ostrava

Locations

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

Ostrava, Czech Republic, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jiří Hynčica

Role: CONTACT

jiri.hyncica@fno.cz

0042059737 ext. 2587

Facility Contacts

Jiří Hynčica

Role: primary

jiri.hyncica@fno.cz

0042059737 ext. 2587

Other Identifiers

06-RVO-FNOs/2023

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KORLCHHK-2023-Mycosis

Identifier Type: -

Identifier Source: org_study_id