Accuracy Between Jabbing-then-suction, Suction-with-jabbing, and Suction-only Transthoracal Needle Aspiration (TTNA) Techniques in Suspected Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Quality of samples from different types of transthoracal needle aspiration (TTNA) technique
研究概览
简要总结
- The objective of this research is to determine the accuracy of different types of lung transthoracal needle aspiration (TTNA) i.e. jabbing-then-suction, suction-with-jabbing, and suction-only TTNA in patients with suspected lung cancer.
- Researchers will compare these techniques to determine whether there are any quality differences in the obtained tumor samples
详细描述
During hospitalization for diagnostic testing, suspected lung cancer patients will undergo a transthoracic biopsy using three TTNA techniques, and core needle biopsy as the gold standard. The biopsy is performed in the operating room under local anesthesia and under the supervision of an anesthesiologist. The biopsy techniques used are routine procedures and therefore not as a new method. After the biopsy is completed, the patient is observed for at least 24 hours to observe potential complications.
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 biopsy results, in a form of 20 cc syringe and slide containing the patient's tissue sample, will be labeled with a code by pulmonologist that will be blinded to the pathologist. The pathologist will then assess the adequacy of the cell count for molecular examination, evaluate the histopathological and cytopathological findings. Statisticians who will process the data are unaware of the allocation of each research item.
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 with suspected lung cancer who will undergo diagnostic testing using ultrasound-guided TTNA of the lung with cell block and core biopsy.
- •Patients aged 18-75 years.
- •The tumor is located peripherally, attached to the chest wall.
排除标准
- •Patient refuses lung biopsy
- •Non-cooperative patient
- •Patient with respiratory failure, on positive pressure ventilation
- •Severe pulmonary emphysema
- •Contralateral pneumonectomy
- •Advanced pulmonary fibrosis
- •Platelet count <100,000/mm3 and international normalized ratio (INR) >1.4
结局指标
主要结局
Quality of samples from different types of transthoracal needle aspiration (TTNA) technique
时间窗: Immediate after biopsy procedure
To determine the quality of samples between the jabbing-then-suction technique, the suction-with-jabbing technique, and the suction-only technique of transthoracic needle aspiration procedures in patients with unsuspected lung cancer. The sample quality assessed includes the adequacy of the number of tumor cells for molecular examination and the concordance between cytology sample of each type of TTNA technique.
次要结局
未报告次要终点
研究者
Siswanto Siswanto
Principal Investigator
Gadjah Mada University