Clinical trial · Interventional
Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cancer | Malignant Lip and Oral Cavity Neoplasm | CURATED_BROADER | 0.80 |
| Squamous Cell Carcinoma of the Oral Cavity or Oropharynx | — | UNRESOLVED | — |
| Tongue Cancer | Malignant Tongue Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard Treatment | Other | — | UNRESOLVED |
| Ultrasound imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- The patients in the control group will have surgery for oral cancer conducted following the current standards for each center.
- interventionNames
- Other: Standard Treatment
- type
- EXPERIMENTAL
- label
- Intervention
- description
- In the intervention group, surgeons will have both in-vivo and ex-vivo ultrasound at to guide the resection and evaluate surgical margins during the procedure. The in-vivo ultrasound will be employed in real-time on the tumor to guide the resection process. The surgeon begins the resection, periodically pausing to obtain real-time images of the resection plane using ultrasound. This is done by repositioning the partially resected specimen, making the resection plane visible as a hyperechoic border on the ultrasound, or by placing a small surgical instrument between the tumor/host interface to visualize the resection plane. Alternatively, the partially resected tumor can be ultrasound scanned from inside-out making the surgical margin visible nearest to the transducer. This is repeated until the tumor is completely removed.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria • Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma. Exclusion criteria * Age \< 18 years. * Oral cancer with suspected bone involvement. * Unable to understand verbal or written information. * Prior radiotherapy treatment of oral cavity cancer. * Tumor not visible on ultrasound.
References
Publications (0)
Data not yet available