Transoral ultrasound versus standard clinical exam to diagnose peritonsillar abscess
Transoral Ultrasound Versus no Transoral Ultrasound in Diagnostic Workup of Peritonsillar Abscess - Proposal for a Multicenter Cluster Randomized Trial
This trial will test whether adding transoral ultrasound helps doctors tell which adults with suspected peritonsillar abscess need drainage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 368 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Copenhagen and 2 other locations) |
| Trial ID | NCT07577232 on ClinicalTrials.gov |
What this trial studies
Adults referred to ENT outpatient clinics in Denmark with suspected peritonsillar abscess are assigned to either receive transoral ultrasound as part of the diagnostic workup or to standard clinical assessment without transoral ultrasound. The trial compares diagnostic decisions, rates of aspiration or incision, and short-term follow-up outcomes between the two approaches. Transoral ultrasound is performed by trained ENT physicians and findings are used to guide whether invasive drainage is performed. The overall goal is to see if adding transoral ultrasound reduces unnecessary invasive procedures and imaging.
Who should consider this trial
Good fit: Adults (≥18) referred to participating ENT outpatient clinics with suspected peritonsillar abscess who can give informed consent and have not yet had drainage are ideal candidates.
Not a fit: Patients needing immediate airway management, those who have already had prior drainage or surgery for the episode, or those unable to tolerate transoral examination are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could more accurately identify true abscesses and reduce unnecessary needle aspirations, incisions, or CT scans.
How similar studies have performed: Several smaller single-center studies have shown improved diagnostic accuracy with transoral ultrasound, but no large multicenter trial has confirmed superiority.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Copenhagen and 2 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.