Surgeon-performed Ultrasound for Real-time Guidance In Oral Cancer Surgeries - A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 13
- 主要终点
- Free surgical margin
研究概览
简要总结
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.
详细描述
Background:
Surgery is the primary treatment for early-stage oral cancer, aiming to completely remove the tumor along with a margin of healthy tissue to ensure a clear surgical margin. However, in up to 50% of cases, the tumor is not entirely removed, leading to higher rates of cancer recurrence and mortality. This challenge often arises from difficulty distinguishing tumor tissue from healthy tissue during the operation. Studies have shown that ultrasound can effectively make this distinction. This project investigates using B-mode in-vivo and ex-vivo ultrasound to assist surgeons in the resection of the tumor. The objective is to enhance accuracy during these surgeries by use of ultrasound. Consequently, we hope to minimize the need for adjuvant therapies, potentially enhancing patients' quality of life and reducing cancer recurrence and mortality rates.
Study population:
Inclusion criteria
• Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for surgical treatment of biopsy-proven T1-T3 oral squamous cell carcinoma.
排除标准
- •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.
研究组 & 干预措施
Control
The patients in the control group will have surgery for oral cancer conducted following the current standards for each center.
干预措施: Standard Treatment (Other)
Intervention
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.
干预措施: Ultrasound imaging (Diagnostic Test)
结局指标
主要结局
Free surgical margin
时间窗: 2 weeks.
Free surgical margin defined as resection margin above 5mm on final histopathology report. Reported as dichotomous variable "free surgical margin yes/no"
次要结局
- Surgeon assessed margins(2 weeks.)
- Dysphagia questionnaire(12 months)
- Cancer recurrence(24 months)
- Survial(24 months)
- Quality of life questionnaire(12 months)
研究者
Tobias Todsen
MD, PhD, Ass. Prof.
Rigshospitalet, Denmark