Ultrasound guidance during surgery for mouth and tongue cancer
Tests ultrasound guidance during surgery in adults with mouth or tongue cancer.
Plain-language title generated from the registry record
Registry title: Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
Key facts
- Where
- Aarhus and Copenhagen, DenmarkSee the 2 sites
Where in Denmark
- Department of Otorhinolaryngology Head and Neck SurgeryAarhus, DenmarkTaking people
- Department of Otorhinolaryngology Head and Neck Surgery and Audiology, RigshospitaletCopenhagen, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tobias Todsen
- Trial code
- NCT07203911
- Record updated
- 13 May 2026
- Original description
The goal of this clinical trial is to improve the surgical treatment of patients with oral cancer. We will explore whether the use of surgeon performed ultrasound during these surgeries result in better tumor removal. We hypothesize that using intraoperative ultrasound to assist the resection results in more frequent clear surgical margins in oral cancer surgeries compared to standard methods. This improvement is associated with a reduced need for post-operative adjuvant therapies such as radiotherapy and reoperation, lower mortality rates, lower cancer recurrence, and enhanced quality of life for patients undergoing surgery for oral cancer.Read full original descriptionShow less
Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
The goal of this clinical trial is to improve the surgical treatment of patients with oral cancer. We will explore whether the use of surgeon performed ultrasound during these surgeries result in better tumor removal. We hypothesize that using intraoperative ultrasound to assist the resection results in more frequent clear surgical margins in oral cancer surgeries compared to standard methods. This improvement is associated with a reduced need for post-operative adjuvant therapies such as radiotherapy and reoperation, lower mortality rates, lower cancer recurrence, and enhanced quality of life for patients undergoing surgery for oral cancer.
Participants will be randomized to either the control or intervention group:
* Control group will receive standard treatment for oral cancer. * Intervention group will in addition to the standard treatment have surgery performed using ultrasound to guide the resection and evaluate resection margins intraoperatively.
Outcomes:
* Number of free surgical margins between control and intervention group. * Intraoperative surgeon assessed surgical margins compared to final histology report. * Dysphagia and quality of life questionnaires. * Recurrence rates. * Mortality rates.
All participant will be followed-up at 3 months and 12 months with:
* MDADI dysphagia questionnaire * EORTC head and neck cancer quality of life questionnaire * Follow-up on recurrrence and mortality.
Inclusion: Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.
Exclusion: Prior radiotherapy treatment of oral cavity cancer; Oral cancer with suspected bone involvement; Age < 18 years; Unable to understand verbal or written information; Tumor not visible on ultrasound.