Ultrasound in Oral Tongue Cancer- Measurement of Depth of Invasion and Intraoperative Help in the Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Intraoperative ultrasound helpful during surgery
研究概览
简要总结
The purpose of this study is to investigate if ultrasound can be helpful in the diagnostic work-up of oral tongue and floor of the mouth cancer. One important factor is how deeply the tumour invades the tissue, the so called depth of invasion (DOI). The investigator will measure DOI with ultrasound and compare the result with the same measurement by magnetic resonance imaging and the microscopic result after the surgery (PAD).
Ultrasound will also be used during surgery of the tumour to investigate if it is useful to better decide the depth of the tumour and thereby improving the operation.
详细描述
The first part of this study will try to answer if ultrasound can improve the preoperative measurement of depth of invasion in tongue cancer and floor of the mouth cancer. The study population is new patients meeting the eligibility criteria presented to the hospital for treatment. Participants will be enrolled only after accepting the oral and written information and signing the written consent paper.
The examiner, one of three otorhinolaryngologists experienced in ultrasound, should be masked to the results of MRI. The first measurement is depth of invasion as well as thickness of the tumour in mm by palpation on awake patient. Thereafter the same measurements by ultrasound (BK Medical Medical flex focus 500, 18Mhz) with gel and protective cover is made with 0,5mm accuracy. Anesthetic gel or lingual block with carbocaine/adrenaline are provided as needed.
At the time of surgery the measurements above are done again on the patient in narcosis before the resection.
Images of the ultrasound measurements are saved for documentation. The results are compared to the corresponding measurements on MRI and also on PAD from the surgical specimen. PAD is considered gold standard.
Power calculation with help of biostatistician yielded a sample size of 55 patients, using a paired test with a 0,050 one-sided significance level will have 80% power to reject the null hypothesis that the proportions are not equivalent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The ultrasound examiner should not be aware of the results of the MRI.
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
- •biopsy verified tongue cancer or floor of the mouth cancer. International Statistical Classification of Diseases and Related Health Problems (ICD) 10 C02.0-2 or C04.0-1
排除标准
- •former surgery in the oral cavity
- •former radiation to the oral cavity
- •floor of the mouth cancer not available to ultrasound investigation
- •floor of the mouth cancer extending to the gingiva
- •patients not suitable for surgery
- •T4 tumours according to TNM 8
- •age under 18
- •patients declining to participate
结局指标
主要结局
Intraoperative ultrasound helpful during surgery
时间窗: up to 6 weeks.
Comparison of surgical margins in resections done with and without the assistance of ultrasound.
Depth of invasion
时间窗: up to 6 weeks.
Depth of invasion in millimeters measured by ultrasound compared to Clinical palpation , MRI and PAD.
次要结局
未报告次要终点