Diagnostic Accuracy of USG guided FNAC of Thyroid Nodules- Prospective Study in a Tertiary Care Hospital.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 1. Assess efficacy of USG guided FNAC in obtaining diagnostic samples from thyroid nodules in terms of percentage of total FNACs performed taking Bethesda 1 as non-diagnostic/inadequate and Bethesda 2-6 as diagnostic/adequate.
研究概览
简要总结
This is a prospective audit assessing the efficacy and diagnostic accuracy of USG guided FNAC of thyroid nodules that will be conducted in 1000 patients in Tata Memorial Hospital, Mumbai over a period of 2 years. The primary aim is to assess efficacy of USG guided FNAC in obtaining diagnostic samples from thyroid nodules and to evaluate the accuracy of USG guided FNAC in predicting the final HPR in patients undergoing surgery. Secondary aim is to assess performance of TIRADS classification on a prospectively maintained database, in risk stratification of thyroid nodules and to study causes of, and possibility of reducing limitations and increasing accuracy of USG guided FNAC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient undergoing USG guided FNAC of thyroid nodules at TMH.
- •Availability of USG images on PACS/reports on EMR.
- •Clinical and cytopathological data on EMR.
排除标准
- •Exclusion criteria:
- •Incomplete medical records or non availability of USG reports.
- •Patients who have undergone USG guided FNAC outside TMC.
- •Patients who have been lost to follow up.
结局指标
主要结局
1. Assess efficacy of USG guided FNAC in obtaining diagnostic samples from thyroid nodules in terms of percentage of total FNACs performed taking Bethesda 1 as non-diagnostic/inadequate and Bethesda 2-6 as diagnostic/adequate.
时间窗: 1. At the time of reporting of FNAC samples which is roughly one week from the date of sample collection. | 2. After obtaining final histopathology report at the time of surgery.
2. To evaluate the accuracy of USG guided FNAC in predicting the final HPR in patients undergoing surgery in terms of True Positive, True Negative, False Positive and False Negative.
时间窗: 1. At the time of reporting of FNAC samples which is roughly one week from the date of sample collection. | 2. After obtaining final histopathology report at the time of surgery.
次要结局
- To assess performance of TIRADS classification on a prospectively maintained database, in risk(stratification of thyroid nodules in terms of correlation of final HPR result in different TIRADS categories.)
研究者
Dr Suman Kumar Ankathi
Tata Memorial Hospital, Mumbai