Diagnostic Accuracy of Different Tru-Cut Needle Sizes in Soft Tissue Sarcomas: A Prospective Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy methods
研究概览
简要总结
Soft tissue sarcomas (STS) require accurate biopsy for diagnosis, grading, and management decisions. Although tru-cut biopsy is widely used, the optimal needle gauge remains uncertain. This study aimed to compare diagnostic accuracy and biopsy concordance rates of 14 G, 16 G, and 18 G tru-cut biopsy needles for extremity STS.
- Is there any difference between the diagnostic accuracy measurements of 14G, 16G and 18G tru-cut biopsy needles for diagnosis of soft tissue sarcomas in extremities?
- Do tumor size, tumor depth, tumor subtype and histological grade of the tumor affect the "matching score"s of biopsies?
- Do tumor size, tumor depth, tumor subtype and histological grade of the tumor affect the biopsy result concordance and/or diagnostic accuracy measurements?
- Does needle gauge effect successful tumoral tissue sampling or prediction of histological grade of soft tissue sarcomas?
详细描述
In 2018, the National Comprehensive Cancer Network (NCCN) endorsed core-needle (tru-cut) biopsy as the preferred diagnostic modality for STSs [14]. They recommend obtaining at least three tissue core blocks through a single stab incision on the skin, with a 14-gauge needle, directing the needle along different trajectories. In clinical practice, both 14 G and 16 G cores are commonly used Although multiple tru-cut needle gauges are used in practice, to our knowledge, an ideal and safe biopsy needle that does not sacrife diagnostic performance has not been defined. This is a randomized prospective disagnostic accuracy study. Therefore we prospectively compared numerous variables (tumor size, tumor depth, subtype, histological grade etc.) with biopsy result concordance and diagnostic accuracy of 14 G, 16 G, and 18 G tru-cut needles in samples obtained from the same tumor for each patient with suspected extremity STS, to determine whether an optimal needle gauge exists.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to the Orthopedic Oncology outpatient clinic at Ankara Bilkent City Hospital with suspected or preliminary findings on physical examination suggesting soft tissue sarcoma.
- •Patients presenting to the Orthopedic Oncology outpatient clinic at Ankara Bilkent City Hospital with suspected or preliminary findings on radiological imaging suggesting soft tissue sarcoma.
- •Patients with soft tissue masses in extremities which require pathological examination
排除标准
- •Patients with a prior diagnosis of the existing mass, coagulation disorders, active infection at the tumor site, a history of previous surgery or radiotherapy to the tumor region, medical conditions contraindicating tru-cut biopsy, or those who did not consent to participate after detailed explanation of the study, were excluded.
结局指标
主要结局
Diagnostic accuracy methods
时间窗: From enrollment to the end of study at 4 months
Sensitivity, specificity, positive predictive value, negative predictive value, false positive rate and false negative rate was analyzed for 3 different needle sizes
次要结局
未报告次要终点