Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Ultrasound imaging: Ultrasound will be performed during surgery in two phases: 1) in-vivo and 2) ex-vivo. In the in-vivo phase surgeons will perform intraoral ultrasound with a small intraoral transducer in order to visualize size and boundaries of tumor. Then the surgeon begins the resection periodically pausing to obtain real-time images of the resection plane and determin if resection is performed at safe distance to the tumor. In the ex-vivo phase the resected tumor will undergo ultrasound by using a motorized mechanical arm designed to hold an ultrasound transducer. This ensures standardized and reproducible scans. The purpose of the ex-vivo scan is to measure the surgical margins at the operating theatre and allow for an immediate re-resection of necessary. Surgeons in the intervention group will also have the possibility of taking biopsies for frozen section analyses.

Standard Treatment: Standard surgical treatment of oral cancer

Study summary

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.

Eligibility

Primary outcome measure(s)

• Surgeon prediction of final margin — 2 weeks.
  Surgeons prediction of deep margin in mm

Trial sites (7)