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Recruiting Not applicable

Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess

NCT07577232 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2025-06-09
Last updated
2026-09-08

Condition(s) studied

Peritonsillar AbscessPeritonsillar CellulitisTonsillitis

Investigational drug(s) / intervention(s)

Transoral Ultrasound

Transoral Ultrasound: A small hockey stick ultrasound to scan the oropharynx through the mouth

Study summary

Peritonsillar abscess (PTA) is a collection of pus between the palatine tonsil and the constrictor muscle. PTA is detected by recognizing characteristics during clinical examination: redness, pain, malaise, trismus, and unilateral peritonsillar swelling. Clinical assessment, including inspection and palpation, is the traditional diagnostic method for patients suspected of having PTA. If PTA is suspected, aspiration with a large-gauge needle or incision is performed to drain the abscess . It can be challenging to distinguish PTA and peritonsillar cellulitis (PTC) based on clinical examination alone. Due to the increased availability of point-of-care ultrasound, it is a part of the diagnostic workup of PTA. Several studies have shown that transoral US can improve the diagnostic accuracy of patients with a suspected PTA. However, no large multicenter study has evaluated whether one of these methods is superior to the other. It is therefore very clinician-dependent whether the patient will have a transoral US performed or not. The investigators hypothesize that transoral US will increase the diagnostic accuracy of PTA compared to solely clinical examination, which is a visual and palpatory assessment. This will result in fewer unnecessary aspiration attempts and overlooked PTAs. Additionally, the investigators wish to investigate the number of aspirations of transoral US-guided needle aspirations compared to aspirations without ultrasound.

Methods This is a cluster randomized study. Patients with suspected PTA will be randomized 1:1 to groups A and B. The cluster randomization will happen weekly using an online randomization tool.

Participants are patients refeered to the outpatient clinic on suspicion of a peritonsillar absces.

The primary outcome is the diagnostic accuracy

The investigators aim to determine whether transoral US is a standard part of the clinical examination by comparing clinical examinations with and without US.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients referred to the ENT outpatient clinic with a suspected PTA. * 18 years of age or older. Exclusion Criteria: * Unable to understand the verbal information, participating in research. * Prior surgical interventions (needle aspiration, surgery, incision) during the course of the disease. * Compromised airways, needing acute airway management.

Primary outcome measure(s)

  • Diagnostic accuracy — From date of randomization until the treatment is completed, assessed up to 2 months.
    Diagnostic accuracy (sensitivity and specificity) of PTA when performing transoral US and by clinical evaluation. A final PTA diagnosis is defined as pus retriveal on the first visit in the outpatient clinic or follow up visit. No later than four days after inclusion. A final non-PTa diagnosis is defined as disease resolution with conservative treatment

Trial sites (3)

FacilityCityRegionStatus
Department of Otorhinolaryngology, Head and Neck Surgery & Audiolog Copenhagen Denmark Recruiting
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, North Zealand Hospital Hillerød Denmark Recruiting
Department of ORL - Head & Neck Surgery and Audiology, Zealand University Hospital, Køge Denmark Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07577232 on ClinicalTrials.gov ↗ ← All trials in Denmark